Skip to content
Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

130 linked reportsMalfunction 128Injury 2
142741542019-01: 1 reports for this device; peer average 4.56/device2019-02: 2 reports for this device; peer average 4.07/device2019-03: 1 reports for this device; peer average 6.92/device2019-04: 0 reports for this device; peer average 10.92/device2019-05: 1 reports for this device; peer average 10.73/device2019-06: 0 reports for this device; peer average 10/device2019-07: 0 reports for this device; peer average 8.45/device2019-08: 0 reports for this device; peer average 13.22/device2019-09: 0 reports for this device; peer average 6.82/device2019-10: 0 reports for this device; peer average 7.62/device2019-11: 1 reports for this device; peer average 25.4/device2019-12: 1 reports for this device; peer average 11.23/device2020-01: 0 reports for this device; peer average 12.8/device2020-02: 0 reports for this device; peer average 5.92/device2020-03: 2 reports for this device; peer average 7.67/device2020-04: 1 reports for this device; peer average 7.83/device2020-05: 0 reports for this device; peer average 8.67/device2020-06: 1 reports for this device; peer average 5.5/device2020-07: 0 reports for this device; peer average 11.4/device2020-08: 0 reports for this device; peer average 19/device2020-09: 0 reports for this device; peer average 8/device2020-10: 1 reports for this device; peer average 6/device2020-11: 1 reports for this device; peer average 6.9/device2020-12: 1 reports for this device; peer average 6.3/device2021-01: 0 reports for this device; peer average 6.56/device2021-02: 0 reports for this device; peer average 3.92/device2021-03: 0 reports for this device; peer average 3.55/device2021-04: 0 reports for this device; peer average 6.31/device2021-05: 0 reports for this device; peer average 9.33/device2021-06: 1 reports for this device; peer average 9.86/device2021-07: 0 reports for this device; peer average 11.29/device2021-08: 0 reports for this device; peer average 11.58/device2021-09: 0 reports for this device; peer average 9.1/device2021-10: 0 reports for this device; peer average 12.5/device2021-11: 0 reports for this device; peer average 8.75/device2021-12: 0 reports for this device; peer average 9.83/device2022-01: 0 reports for this device; peer average 11.67/device2022-02: 0 reports for this device; peer average 6.3/device2022-03: 0 reports for this device; peer average 9.54/device2022-04: 1 reports for this device; peer average 8.4/device2022-05: 0 reports for this device; peer average 6.5/device2022-06: 0 reports for this device; peer average 4.48/device2022-07: 0 reports for this device; peer average 4.8/device2022-08: 0 reports for this device; peer average 6.43/device2022-09: 0 reports for this device; peer average 2.92/device2022-10: 1 reports for this device; peer average 6.56/device2022-11: 0 reports for this device; peer average 9.8/device2022-12: 0 reports for this device; peer average 12.5/device2023-01: 0 reports for this device; peer average 6.67/device2023-02: 0 reports for this device; peer average 8.7/device2023-03: 0 reports for this device; peer average 11.08/device2023-04: 0 reports for this device; peer average 9.8/device2023-05: 0 reports for this device; peer average 8.5/device2023-06: 0 reports for this device; peer average 9.2/device2023-07: 1 reports for this device; peer average 8/device2023-08: 0 reports for this device; peer average 12.08/device2023-09: 0 reports for this device; peer average 13.22/device2023-10: 0 reports for this device; peer average 9.75/device2023-11: 0 reports for this device; peer average 7.54/device2023-12: 0 reports for this device; peer average 12.27/device2024-01: 0 reports for this device; peer average 7.33/device2024-02: 1 reports for this device; peer average 11.36/device2024-03: 3 reports for this device; peer average 10.5/device2024-04: 1 reports for this device; peer average 10.42/device2024-05: 1 reports for this device; peer average 11.58/device2024-06: 0 reports for this device; peer average 10.5/device2024-07: 0 reports for this device; peer average 10.82/device2024-08: 0 reports for this device; peer average 10.64/device2024-09: 3 reports for this device; peer average 12/device2024-10: 3 reports for this device; peer average 12/device2024-11: 6 reports for this device; peer average 12.31/device2024-12: 0 reports for this device; peer average 16.73/device2025-01: 3 reports for this device; peer average 14.9/device2025-02: 0 reports for this device; peer average 10.7/device2025-03: 6 reports for this device; peer average 10.58/device2025-04: 3 reports for this device; peer average 10.42/device2025-05: 9 reports for this device; peer average 18.58/device2025-06: 54 reports for this device; peer average 12.17/device2025-07: 3 reports for this device; peer average 8.82/device2025-08: 0 reports for this device; peer average 11.7/device2025-09: 2 reports for this device; peer average 6.77/device2025-10: 2 reports for this device; peer average 9.89/device2025-11: 3 reports for this device; peer average 14.8/device2025-12: 0 reports for this device; peer average 18/device2026-01: 0 reports for this device; peer average 13/device2026-02: 6 reports for this device; peer average 9.85/device2026-03: 0 reports for this device; peer average 12.4/device2026-04: 3 reports for this device; peer average 10.4/device2026-05: 0 reports for this device; peer average 7.09/device2026-06: 0 reports for this device; peer average 10.7/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0114.56
2019-0224.07
2019-0316.92
2019-04010.92
2019-05110.73
2019-06010
2019-0708.45
2019-08013.22
2019-0906.82
2019-1007.62
2019-11125.4
2019-12111.23
2020-01012.8
2020-0205.92
2020-0327.67
2020-0417.83
2020-0508.67
2020-0615.5
2020-07011.4
2020-08019
2020-0908
2020-1016
2020-1116.9
2020-1216.3
2021-0106.56
2021-0203.92
2021-0303.55
2021-0406.31
2021-0509.33
2021-0619.86
2021-07011.29
2021-08011.58
2021-0909.1
2021-10012.5
2021-1108.75
2021-1209.83
2022-01011.67
2022-0206.3
2022-0309.54
2022-0418.4
2022-0506.5
2022-0604.48
2022-0704.8
2022-0806.43
2022-0902.92
2022-1016.56
2022-1109.8
2022-12012.5
2023-0106.67
2023-0208.7
2023-03011.08
2023-0409.8
2023-0508.5
2023-0609.2
2023-0718
2023-08012.08
2023-09013.22
2023-1009.75
2023-1107.54
2023-12012.27
2024-0107.33
2024-02111.36
2024-03310.5
2024-04110.42
2024-05111.58
2024-06010.5
2024-07010.82
2024-08010.64
2024-09312
2024-10312
2024-11612.31
2024-12016.73
2025-01314.9
2025-02010.7
2025-03610.58
2025-04310.42
2025-05918.58
2025-065412.17
2025-0738.82
2025-08011.7
2025-0926.77
2025-1029.89
2025-11314.8
2025-12018
2026-01013
2026-0269.85
2026-03012.4
2026-04310.4
2026-0507.09
2026-06010.7
This device (reports/month)Average device in PKL (reports/device/month)
Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-04-231528319-2026-00036MalfunctionAvailablecatalog number
2026-02-261528319-2026-00016MalfunctionAvailablecatalog number
2026-02-201528319-2026-00015MalfunctionAvailablecatalog number
2025-11-181528319-2025-00106MalfunctionAvailablecatalog number
2025-10-101528319-2025-00099MalfunctionAvailablecatalog number
2025-09-301528319-2025-00098MalfunctionAvailablecatalog number
2025-07-241528319-2025-00080MalfunctionAvailablecatalog number
2025-06-271528319-2025-00070MalfunctionAvailablecatalog number
2025-06-271528319-2025-00069MalfunctionAvailablecatalog number
2025-06-271528319-2025-00071MalfunctionAvailablecatalog number
2025-06-261528319-2025-00067MalfunctionAvailablecatalog number
2025-06-261528319-2025-00066MalfunctionAvailablecatalog number
2025-06-251528319-2025-00068MalfunctionAvailablecatalog number
2025-06-251528319-2025-00064MalfunctionAvailablecatalog number
2025-06-241528319-2025-00052MalfunctionAvailablecatalog number

Showing the most recent 59 of 130 linked reports.

Showing 1–15 of 59
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

Similar devices
  • Alton Alton (Shanghai) Medical Instruments Co., Ltd.
  • Alton Alton (Shanghai) Medical Instruments Co., Ltd.
  • Alton Alton (Shanghai) Medical Instruments Co., Ltd.
  • Alton Alton (Shanghai) Medical Instruments Co., Ltd.
  • Alton Alton (Shanghai) Medical Instruments Co., Ltd.
  • Alton Alton (Shanghai) Medical Instruments Co., Ltd.
  • Alton Alton (Shanghai) Medical Instruments Co., Ltd.
  • Alton Alton (Shanghai) Medical Instruments Co., Ltd.
  • Anrei Anrei Medical(HZ) Co.,Ltd.
  • Anrei Anrei Medical(HZ) Co.,Ltd.
  • Anrei Anrei Medical(HZ) Co.,Ltd.
  • Anrei Anrei Medical(HZ) Co.,Ltd.
Select up to two to place side-by-side with this device.