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
- 510(k)K241617Substantially equivalent (SESE) · 2025-02-28clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-08-16 | VAI | Voluntary action indicated | SSL Manufacturing (Thailand) LTD. | 2 |
| 2022-09-01 | NAI | No action indicated | Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. | 0 |
| 2016-05-12 | VAI | Voluntary action indicated | Reckitt Benckiser, LLC | 4 |
| 2016-05-12 | VAI | Voluntary action indicated | Reckitt Benckiser, LLC | 4 |
| 2015-05-15 | NAI | No action indicated | RB Health (US) LLC | 0 |
| 2014-07-10 | NAI | No action indicated | Qingdao London Durex Co., Ltd. | 0 |
| 2012-06-20 | NAI | No action indicated | SSL Manufacturing (Thailand) LTD. | 0 |
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