MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-13 for ACTICOAT 10X10CM CTN 12 66000791 manufactured by Smith & Nephew Medical Ltd..
[91876402]
Patient Sequence No: 1, Text Type: N, H10
[91876403]
It was reported that a patient experience damage to the wound bed following dressing removal. The dressing had adhered causing bleeding on removal.
Patient Sequence No: 1, Text Type: D, B5
[108932460]
Patient Sequence No: 1, Text Type: N, H10
[108932461]
There was only a little bleeding and this stopped by itself. No treatment was needed.
Patient Sequence No: 1, Text Type: D, B5
[109155524]
Please review attached for investigation results. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2017-00280 |
| MDR Report Key | 7026733 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-13 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-11-10 |
| Date Mfgr Received | 2017-11-10 |
| Date Added to Maude | 2017-11-13 |
| 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 28N |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 28N |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTICOAT 10X10CM CTN 12 |
| Generic Name | DRESSING, WOUND AND BURN, OCCLUSIVE |
| Product Code | MGP |
| Date Received | 2017-11-13 |
| Catalog Number | 66000791 |
| Lot Number | 1611 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU3 28N UK HU3 28N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-13 |