MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-06-22 for UNNAFLEX manufactured by Convatec, Div. Of E.r. Squibb & Sons, Inc..
[80640]
Convatec physician has reviewed all of the available info and notes that diagnostic testing was not performed to determine the etiology of the pt's dermatitis. It is possible that the dermatitis was due to sensitization to zinc oxide or another component of unnaflex elastic unna boot. However, dermatitis may be related to a variety of causative agents ranging from concomitant medications to soaps or lotions. Without definitive diagnostic testing or methodical elimination of suspect agents, a causal relationship to any agent is at best speculative. Based upon co's evaluation, frequency and severity data does not show an increase and does not markedly differ from what is considered usual for this device. Furthermore, convatec has determined that this incident is not reportable as it does not meet the criteria for reportability under the medical device reporting regulation 21 cfr, section 803. 24.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006318 |
| MDR Report Key | 22710 |
| Date Received | 1995-06-22 |
| Date of Report | 1995-03-15 |
| Date of Event | 1995-03-05 |
| 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 | UNNAFLEX |
| Generic Name | BOOT |
| Product Code | FQL |
| Date Received | 1995-06-22 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22904 |
| 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 |