MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-18 for DEWRAP 46-333 manufactured by Deroyal Industries.
[951360]
Bilateral lower extremities wrapped in dewrap for severe lymphedema and ulcerations - developed blisters, pain and itching.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008345 |
| MDR Report Key | 1167281 |
| Date Received | 2008-09-18 |
| Date of Report | 2008-09-18 |
| Date of Event | 2008-07-24 |
| Date Added to Maude | 2008-09-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEWRAP |
| Generic Name | COMPRESSION BANDAGES |
| Product Code | MHW |
| Date Received | 2008-09-18 |
| Model Number | 46-333 |
| Catalog Number | 46-333 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1201165 |
| Manufacturer | DEROYAL INDUSTRIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-18 |