MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-03-04 for DERMATOME BLADES 00880000010 manufactured by Zimmer Surgical, Inc..
[182233593]
This event has been recorded by zimmer biomet under (b)(4). Once the investigation is completed, a follow-up/final report will be submitted. Event date: (b)(6) 2019.
Patient Sequence No: 1, Text Type: N, H10
[182233594]
It was reported during a skin graft procedure, an unintended laceration occurred due to incorrect placement of the blade inside the dermatome machine. The blade was removed and replaced correctly. The laceration was repaired and skin graft procedure was completed without additional complications. No additional consequences have been reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00251 |
| MDR Report Key | 9787676 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DERMATOME BLADES |
| Generic Name | DERMATOME BLADE, SINGLE-USE |
| Product Code | GFD |
| Date Received | 2020-03-04 |
| Catalog Number | 00880000010 |
| Lot Number | 64357957 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-03-04 |