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 |
|---|---|---|---|---|
| 2018-08-30 | NAI | No action indicated | REMINGTON MEDICAL, S.A. | 0 |
| 2018-01-11 | NAI | No action indicated | Remington Medical, Inc. | 0 |
| 2018-01-11 | NAI | No action indicated | Remington Medical, Inc. | 0 |
| 2018-01-11 | NAI | No action indicated | Remington Medical, Inc. | 0 |
| 2018-01-11 | NAI | No action indicated | Remington Medical, Inc. | 0 |
| 2015-09-14 | WL | Warning Letter | REMINGTON MEDICAL, S.A. | — |
| 2015-06-25 | NAI | No action indicated | REMINGTON MEDICAL, S.A. | 0 |
| 2014-11-24 | NAI | No action indicated | Remington Medical, Inc. | 0 |
| 2014-11-24 | VAI | Voluntary action indicated | Remington Medical, Inc. | 3 |
| 2014-11-24 | NAI | No action indicated | Remington Medical, Inc. | 0 |
| 2014-11-24 | VAI | Voluntary action indicated | Remington Medical, Inc. | 3 |
| 2014-08-14 | OAI | Official action indicated | REMINGTON MEDICAL, S.A. | 9 |
| 2012-06-06 | VAI | Voluntary action indicated | Remington Medical, Inc. | 1 |
| 2012-06-06 | VAI | Voluntary action indicated | Remington Medical, Inc. | 2 |
| 2012-06-06 | VAI | Voluntary action indicated | Remington Medical, Inc. | 2 |
| 2012-06-06 | VAI | Voluntary action indicated | Remington Medical, Inc. | 1 |
| 2010-12-17 | VAI | Voluntary action indicated | Remington Medical, Inc. | 5 |
| 2010-12-17 | VAI | Voluntary action indicated | Remington Medical, Inc. | 1 |
| 2010-12-17 | VAI | Voluntary action indicated | Remington Medical, Inc. | 5 |
| 2010-12-17 | VAI | Voluntary action indicated | Remington Medical, Inc. | 1 |
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