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.
8 linked reportsMalfunction 8
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.4
2019-03
0
4
2019-04
0
1.25
2019-05
0
1
2019-06
1
7.67
2019-07
0
2
2019-08
1
2
2019-09
0
2.17
2019-10
0
5
2019-11
0
2.5
2019-12
0
2.86
2020-01
0
2
2020-02
0
2
2020-03
0
2.43
2020-04
0
2.13
2020-05
0
1
2020-06
0
1
2020-07
0
1.25
2020-08
0
1
2020-09
1
1.25
2020-10
0
1.4
2020-11
2
1.67
2020-12
3
2
2021-01
0
1
2021-02
0
1.67
2021-03
0
2
2021-04
0
2.2
2021-05
0
1.44
2021-06
0
1.7
2021-07
0
2.56
2021-08
0
1
2021-09
0
1.33
2021-10
0
1
2021-11
0
2.6
2021-12
0
1.33
2022-01
0
2
2022-02
0
1.67
2022-03
0
2.25
2022-04
0
2.67
2022-05
0
1.5
2022-06
0
2.43
2022-07
0
1.29
2022-08
0
1
2022-09
0
1.33
2022-10
0
1.4
2022-11
0
1
2022-12
0
1.33
2023-01
0
1
2023-02
0
2.25
2023-03
0
2.44
2023-04
0
1.67
2023-05
0
1
2023-06
0
1.25
2023-07
0
1.5
2023-08
0
1
2023-09
0
2.2
2023-10
0
1
2023-11
0
1.67
2023-12
0
1
2024-01
0
1.75
2024-02
0
1.6
2024-03
0
1.5
2024-04
0
2.11
2024-05
0
1
2024-06
0
6.5
2024-07
0
3.25
2024-08
0
7.5
2024-09
0
3.57
2024-10
0
7.8
2024-11
0
1.14
2024-12
0
2.33
2025-01
0
1.44
2025-02
0
1.67
2025-03
0
7.14
2025-04
0
1.6
2025-05
0
1.13
2025-06
0
1.57
2025-07
0
1
2025-08
0
1.71
2025-09
0
1.67
2025-10
0
1
2025-11
0
3.4
2025-12
0
2.11
2026-01
0
2.17
2026-02
0
3.6
2026-03
0
2.22
2026-04
0
3.36
2026-05
0
1.71
2026-06
0
1.17
This device (reports/month)Average device in KPE (reports/device/month)
Failure-mode summaryAI-generated
8 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2024-06-03
Z-2642-2024
Class II
Open, Classified
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.