MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-09-28 for CONFORMANT 2 WOUND VIEL manufactured by Smith & Nephew Inc., Wound Management.
[717844]
Conformant wound veil was placed over a wound that had an enzymatic debriding agent, accuzymes, already inside the wound. The cover dressing was removed after one day, and the nurse said the wound veil had "melted into the wound" and had to be "debrided out". To remove the conformant, pt was put in the shower for 2 hours until the dressing loosened enough to be removed. There was extensive bleeding from the wound, and the pt had pain. Patient was given morphine and toradol for the pain. The in-patient stay was not lengthened because of this issue. At this time, the patient's wound is healing nicely.
Patient Sequence No: 1, Text Type: D, B5
[7859075]
Part number, lot number and customer sample were not provided for the investigation. A follow-up report will be submitted following receipt of additional info and investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017593-2007-00015 |
| MDR Report Key | 920710 |
| Report Source | 05,06 |
| Date Received | 2007-09-28 |
| Date of Report | 2007-08-28 |
| Date of Event | 2007-08-28 |
| Date Mfgr Received | 2007-08-28 |
| Date Added to Maude | 2007-10-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JIM IRVIN |
| Manufacturer Street | 11775 STARKEY RD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273921261 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFORMANT 2 WOUND VIEL |
| Generic Name | BANDAGE, BURN AND WOUND OCCLUSIVE (MGP) |
| Product Code | MGP |
| Date Received | 2007-09-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 894497 |
| Manufacturer | SMITH & NEPHEW INC., WOUND MANAGEMENT |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-28 |