MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-16 for DYNAREX UNNA BOOT BANDAGE manufactured by Dynarex.
[67950222]
Open box of dynarex flexible unna boot bandage with calamine and found mold on the product lot number is: 63370 expiration date: 03/2021, mfr: (b)(4). Opened to use on a pt but saw mold so was not used. You may contact me at: (b)(6). Route: topical. Diagnosis or reason for use: lymphedema. Is the product over-the-counter: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067965 |
| MDR Report Key | 6345530 |
| Date Received | 2017-02-16 |
| Date of Report | 2017-02-15 |
| Date of Event | 2017-02-15 |
| Date Added to Maude | 2017-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DYNAREX UNNA BOOT BANDAGE |
| Generic Name | DYNAREX UNNA BOOT BANDAGE |
| Product Code | NEC |
| Date Received | 2017-02-16 |
| Lot Number | 63370 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DYNAREX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-16 |