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 |
|---|---|---|---|---|
| 2015-02-04 | NAI | No action indicated | Apex Medical (Kunshan) Corp. | 2 |
| 2014-11-07 | VAI | Voluntary action indicated | Wellell Inc | 0 |
| 2014-11-07 | VAI | Voluntary action indicated | Wellell Inc | 0 |
| 2012-02-23 | VAI | Voluntary action indicated | Wellell Inc | 2 |
| 2012-02-23 | VAI | Voluntary action indicated | Wellell Inc | 2 |
| 2011-12-01 | NAI | No action indicated | Apex Medical (Kunshan) Corp. | 0 |
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