MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-06-22 for UNNA-FLEX manufactured by Convatec, Div Of E.r. Squibb & Sons, Inc..
[14471]
Our convatec physician has reviewed all of the available info & notes that diagnostic testing was not performed to determine the etiology of the pt's dermatitis. Without definitive diagnostic testing or methodical elimination of suspect agents, a causal relationship to any agen is at best speculative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006317 |
| MDR Report Key | 22708 |
| Date Received | 1995-06-22 |
| Date of Report | 1995-03-03 |
| Date of Event | 1995-01-01 |
| Date Added to Maude | 1995-06-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNNA-FLEX |
| Generic Name | COMPRESSION DRESSING |
| Product Code | FQL |
| Date Received | 1995-06-22 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22902 |
| Manufacturer | CONVATEC, DIV OF E.R. SQUIBB & SONS, INC. |
| Manufacturer Address | GREENSBORO NC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-06-22 |