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.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-04-14 | VAI | Voluntary action indicated | Cogentix Medical, Inc. | 1 |
| 2022-04-14 | VAI | Voluntary action indicated | Cogentix Medical, Inc. | 1 |
| 2020-02-28 | NAI | No action indicated | Cogentix Medical LLC | 0 |
| 2020-02-28 | NAI | No action indicated | Cogentix Medical LLC | 0 |
| 2017-08-31 | NAI | No action indicated | Cogentix Medical LLC | 0 |
| 2017-08-31 | NAI | No action indicated | Cogentix Medical LLC | 0 |
| 2014-08-08 | VAI | Voluntary action indicated | Cogentix Medical, Inc. | 2 |
| 2014-08-08 | VAI | Voluntary action indicated | Cogentix Medical, Inc. | 2 |
| 2013-05-01 | VAI | Voluntary action indicated | Cogentix Medical, Inc. | 2 |
| 2013-05-01 | VAI | Voluntary action indicated | Cogentix Medical, Inc. | 2 |
| 2012-06-01 | NAI | No action indicated | Cogentix Medical LLC | 0 |
| 2012-06-01 | NAI | No action indicated | Cogentix Medical LLC | 0 |
| 2011-02-11 | VAI | Voluntary action indicated | Cogentix Medical, Inc. | 4 |
| 2011-02-11 | VAI | Voluntary action indicated | Cogentix Medical, Inc. | 4 |
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