MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for ZIMMER AIR DERMATOME 008801-001-00 manufactured by Zimmer Surgical Inc..
[182543663]
The dermatome was not functioning properly. Instead of shaving off a thin layer of skin, it made and incisional wound. The blade was applied correctly. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093547 |
| MDR Report Key | 9799420 |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-17 |
| Date Added to Maude | 2020-03-06 |
| 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | ZIMMER AIR DERMATOME |
| Generic Name | DERMATOME |
| Product Code | GFD |
| Date Received | 2020-03-05 |
| Model Number | 008801-001-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL INC. |
| Manufacturer Address | DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-05 |