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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.

4 linked reportsMalfunction 4
61319252020-03: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 5.5/device2023-12: 0 reports for this device; peer average 2.33/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 25/device2024-06: 0 reports for this device; peer average 10/device2024-07: 0 reports for this device; peer average 12/device2024-08: 0 reports for this device; peer average 11/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 16/device2025-02: 0 reports for this device; peer average 5.5/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 4/device2025-08: 0 reports for this device; peer average 2.5/device2025-09: 0 reports for this device; peer average 2.5/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 6/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 2.5/device2026-03: 0 reports for this device; peer average 1.67/device2026-04: 2 reports for this device; peer average 2/device2026-05: 2 reports for this device; peer average 2.33/device2026-06: 0 reports for this device; peer average 2.86/device0310081007120611120102030405060708091011120204050809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0301
2020-1001
2021-0801
2021-1002
2022-0701
2022-1201
2023-0601
2023-1105.5
2023-1202.33
2024-0101
2024-0201
2024-0301
2024-0401
2024-05025
2024-06010
2024-07012
2024-08011
2024-0901.5
2024-1001
2024-1101
2024-12016
2025-0205.5
2025-0401
2025-0504
2025-0802.5
2025-0902.5
2025-1001.5
2025-1106
2025-1201
2026-0101
2026-0202.5
2026-0301.67
2026-0422
2026-0522.33
2026-0602.86
This device (reports/month)Average device in DXQ (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-05-031417592-2026-00770MalfunctionAvailablecatalog number
2026-04-291417592-2026-00597MalfunctionAvailablecatalog number

Showing the most recent 2 of 4 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-03-26WLWarning LetterMedLine Industries, LP (NAMIC Division)—
2025-12-12OAIOfficial action indicatedMedLine Industries, LP (NAMIC Division)5
2025-04-22NAINo action indicatedMICROTEK MEDICAL LLC0
2024-03-18WLWarning LetterMedline Industries, LP—
2024-03-18WLWarning LetterMedline Industries, LP—
2024-01-29NAINo action indicatedMedline Industries LP0
2024-01-29NAINo action indicatedMedline Industries LP0
2024-01-22OAIOfficial action indicatedMedline Industries, LP5
2024-01-22OAIOfficial action indicatedMedline Industries, LP5
2023-11-01NAINo action indicatedMedline Industries, LP0
2023-11-01NAINo action indicatedMedline Industries, LP0
2023-07-26NAINo action indicatedMedline Industries LP0
2023-07-26NAINo action indicatedMedline Industries LP0
2023-02-10NAINo action indicatedCenturion Medical Products, LP0
2022-04-06VAIVoluntary action indicatedMedline Industries, LP0
2022-04-06VAIVoluntary action indicatedMedline Industries, LP0
2022-04-05NAINo action indicatedCenturion Medical Products, LP0
2022-03-28NAINo action indicatedMedline Industries, LP0
2022-03-28NAINo action indicatedMedline Industries, LP0
2020-06-11WLWarning LetterCenturion Medical Products, LP—
2019-11-01OAIOfficial action indicatedCenturion Medical Products, LP5
2019-10-17NAINo action indicatedMedline Industries LP0
2019-10-17NAINo action indicatedMedline Industries LP0
2019-08-20OAIOfficial action indicatedCenturion Medical Products, LP5
2014-11-07WLWarning LetterExcelsior Medical LLC—
2014-03-11WLWarning LetterMedline Industries, LP—
2014-03-11WLWarning LetterMedline Industries, LP—
2010-03-12WLWarning LetterMedline Industries, LP—
2010-03-12WLWarning LetterMedline Industries, LP—
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