MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-25 for ZIMMER BIOMET VARIOUS KITS CONTAINING ACDA 800-1003A manufactured by Zimmer Biomet.
[51240263]
Infection in surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063688 |
| MDR Report Key | 5829656 |
| Date Received | 2016-07-25 |
| Date Added to Maude | 2016-07-28 |
| 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 BIOMET VARIOUS KITS CONTAINING ACDA |
| Generic Name | ZIMMER BIOMET VARIOUS KITS CONTAINING ACDA |
| Product Code | KSS |
| Date Received | 2016-07-25 |
| Catalog Number | 800-1003A |
| Lot Number | 402274 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET |
| Manufacturer Address | PO BOX 587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-25 |