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 |
|---|---|---|---|---|
| 2018-01-18 | VAI | Voluntary action indicated | Covalon Technologies Ltd. | 5 |
| 2018-01-18 | VAI | Voluntary action indicated | Covalon Technologies Ltd. | 5 |
| 2014-04-24 | NAI | No action indicated | Covalon Technologies Ltd. | 0 |
| 2014-04-24 | NAI | No action indicated | Covalon Technologies Ltd. | 0 |
Similar devices
- BIATAIN ADVANCED MEDICAL SOLUTIONS LIMITED
- "ACTICOAT 7 4"" X 5""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT 7 2"" X 2""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT 7 6"" X 6""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 16"" X 16""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 2"" X 2""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 4"" X 4""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 4"" X 48""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 4"" X 8""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 8"" X 16""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX7 16"" X 16""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX7 2"" x 2""" SMITH & NEPHEW MEDICAL LIMITED
Select up to two to place side-by-side with this device.