MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-06 for UNK manufactured by Unk.
[358014]
Pt undergoing total knee replacement; mallet used cracked and left residue on surgeon's gloves and assistant's gloves. Operative site irrigated with copious amount of irrigation. Case completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 505954 |
| MDR Report Key | 505954 |
| Date Received | 2004-01-06 |
| Date of Report | 2004-01-05 |
| Date of Event | 2003-12-17 |
| Date Facility Aware | 2003-12-31 |
| Report Date | 2004-01-05 |
| Date Reported to FDA | 2004-01-05 |
| Date Added to Maude | 2004-01-14 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | UNK |
| Product Code | GFJ |
| Date Received | 2004-01-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 494826 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-01-06 |