MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-06 for UNKNOWN ACTICOAT manufactured by Smith & Nephew Medical Ltd..
[91055349]
Patient Sequence No: 1, Text Type: N, H10
[91055350]
It was reported that a patient presented at a hospital with acticoat adhered to the wound. It was applied 3 days prior to presentation and was stuck to the wound; it could not be removed by saturating the dressing. The surrounding tissue began to macerate and it appeared that the skin grew into the dressing. Patient outcome not confirmed.
Patient Sequence No: 1, Text Type: D, B5
[107865959]
[(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2017-00250 |
| MDR Report Key | 7002535 |
| Date Received | 2017-11-06 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-09-28 |
| Date Mfgr Received | 2017-09-28 |
| Date Added to Maude | 2017-11-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MARKUS POETTKER |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 2BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ACTICOAT |
| Generic Name | DRESSING, WOUND AND BURN, OCCLUSIVE |
| Product Code | MGP |
| Date Received | 2017-11-06 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-06 |