MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-01-11 for OPSITE TRANSPARENT ADHESIVE DRESSING UNK manufactured by Smith & Nephew Wound Mgmt Division.
[146770]
The pt contacted smith & nephew via email regarding an incident with opsite dressing. The pt was undergoing a skin graph in which the replacement skin was taken off the right thigh. An opsite dressing bandage was placed over the 2 by 4" area. After approximately 8 hours, red, large blisters appeared under the dressing where the green tape handles are located (outer right and left side of the dressing). Normally, these green handles are used for applying the dressing and then removed. The pt indicated that the blisters have become permanent scars. Repeated unsuccessful attempts have been made to contact the pt in order to gain additional info regarding the incident, treatment, current condition and part/lot number of the product. Should info become available, an additional report will be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017593-2000-00001 |
| MDR Report Key | 261748 |
| Report Source | 04 |
| Date Received | 2000-01-11 |
| Date of Report | 2000-01-06 |
| Date Mfgr Received | 1999-12-06 |
| Date Added to Maude | 2000-02-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JIM IRVIN, VP |
| Manufacturer Street | 11775 STARKEY RD PO BOX 1970 |
| Manufacturer City | LARGO FL 337791970 |
| Manufacturer Country | US |
| Manufacturer Postal | 337791970 |
| Manufacturer Phone | 7273921261 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPSITE TRANSPARENT ADHESIVE DRESSING |
| Generic Name | MEDICAL ADHESIVE TAPE |
| Product Code | MCA |
| Date Received | 2000-01-11 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 253499 |
| Manufacturer | SMITH & NEPHEW WOUND MGMT DIVISION |
| Manufacturer Address | 11775 STARKEY RD. LARGO FL 33773 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-01-11 |