MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for ZIMMER AIR DERMATOME manufactured by Zimmer Biomet.
[182298223]
The zimmer dermatome blade was put on upside down (it can be placed in the device either way) and a full thickness skin graft was taken, instead of the intended split thickness. Concern that blade can go on either way.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9785291 |
| MDR Report Key | 9785291 |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-09 |
| Date Facility Aware | 2020-02-11 |
| Report Date | 2020-02-20 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 2020-03-04 |
| Lot Number | 112500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET |
| Manufacturer Address | 345 EAST MAIN STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-04 |