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.
3 linked reportsMalfunction 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 13.19 |
| 2019-02 | 0 | 3.29 |
| 2019-03 | 0 | 3.78 |
| 2019-04 | 0 | 4.27 |
| 2019-05 | 0 | 4.18 |
| 2019-06 | 0 | 3.67 |
| 2019-07 | 0 | 3.38 |
| 2019-08 | 0 | 3.9 |
| 2019-09 | 0 | 4.55 |
| 2019-10 | 0 | 4.93 |
| 2019-11 | 0 | 4.56 |
| 2019-12 | 0 | 5.21 |
| 2020-01 | 0 | 5.18 |
| 2020-02 | 0 | 5.84 |
| 2020-03 | 0 | 5.61 |
| 2020-04 | 0 | 4.89 |
| 2020-05 | 0 | 3.51 |
| 2020-06 | 0 | 5.69 |
| 2020-07 | 0 | 6.15 |
| 2020-08 | 0 | 5.62 |
| 2020-09 | 0 | 7.33 |
| 2020-10 | 1 | 8.59 |
| 2020-11 | 0 | 5.88 |
| 2020-12 | 0 | 8.73 |
| 2021-01 | 1 | 6.22 |
| 2021-02 | 0 | 5.77 |
| 2021-03 | 0 | 7.8 |
| 2021-04 | 0 | 6.1 |
| 2021-05 | 0 | 5.51 |
| 2021-06 | 0 | 5.7 |
| 2021-07 | 0 | 4.89 |
| 2021-08 | 0 | 5.25 |
| 2021-09 | 0 | 3.47 |
| 2021-10 | 0 | 5.1 |
| 2021-11 | 0 | 3.78 |
| 2021-12 | 0 | 5.41 |
| 2022-01 | 0 | 4.97 |
| 2022-02 | 0 | 3.68 |
| 2022-03 | 0 | 4.39 |
| 2022-04 | 0 | 4.17 |
| 2022-05 | 0 | 4.13 |
| 2022-06 | 0 | 4.35 |
| 2022-07 | 0 | 4.38 |
| 2022-08 | 0 | 4.33 |
| 2022-09 | 0 | 4.1 |
| 2022-10 | 0 | 3.98 |
| 2022-11 | 0 | 4.58 |
| 2022-12 | 0 | 4.6 |
| 2023-01 | 0 | 5.09 |
| 2023-02 | 0 | 4.25 |
| 2023-03 | 0 | 5.19 |
| 2023-04 | 0 | 4.82 |
| 2023-05 | 0 | 4.71 |
| 2023-06 | 0 | 4.43 |
| 2023-07 | 0 | 4.24 |
| 2023-08 | 0 | 4.98 |
| 2023-09 | 0 | 4.83 |
| 2023-10 | 0 | 4.36 |
| 2023-11 | 0 | 7.71 |
| 2023-12 | 0 | 8.69 |
| 2024-01 | 0 | 6.2 |
| 2024-02 | 0 | 6.38 |
| 2024-03 | 0 | 5.26 |
| 2024-04 | 0 | 5.97 |
| 2024-05 | 0 | 8.82 |
| 2024-06 | 0 | 8.63 |
| 2024-07 | 0 | 4.91 |
| 2024-08 | 0 | 4.86 |
| 2024-09 | 0 | 4.76 |
| 2024-10 | 0 | 6.15 |
| 2024-11 | 0 | 5.22 |
| 2024-12 | 0 | 7.47 |
| 2025-01 | 0 | 8.64 |
| 2025-02 | 0 | 6.11 |
| 2025-03 | 0 | 4.97 |
| 2025-04 | 0 | 5.43 |
| 2025-05 | 1 | 5.9 |
| 2025-06 | 0 | 5 |
| 2025-07 | 0 | 5.22 |
| 2025-08 | 0 | 4.31 |
| 2025-09 | 0 | 4.58 |
| 2025-10 | 0 | 5.02 |
| 2025-11 | 0 | 5.59 |
| 2025-12 | 0 | 5.94 |
| 2026-01 | 0 | 5.53 |
| 2026-02 | 0 | 5.52 |
| 2026-03 | 0 | 5.59 |
| 2026-04 | 0 | 6.82 |
| 2026-05 | 0 | 4.7 |
| 2026-06 | 0 | 4.85 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2013-05-15 | Z-1682-2013 | Class II | Terminated | A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.Distribution: US Nationwide Distribution | 356,728 units | clearance family |
| 2013-05-15 | Z-1683-2013 | Class II | Terminated | A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.Distribution: US Nationwide Distribution | 530,488 units | clearance family |
| 2013-05-15 | Z-1684-2013 | Class II | Terminated | A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.Distribution: US Nationwide Distribution | 249,576 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-05-20 | 1416980-2025-02935 | Malfunction | Available | exact di |
| 2021-01-14 | 1416980-2020-08492 | Malfunction | Available | exact di |
| 2020-10-05 | 1416980-2020-06196 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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