MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-11-14 for BIOMET manufactured by Biomet.
[2996912]
Pt undergoing hip revision placed in lateral position on biomet peg board, padded with gelpad. Following procedure, determined pt sustained gaping wound to lateral abdomen. Hole in gelpad, injury from the peg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2850791 |
| MDR Report Key | 2850791 |
| Report Source | 99 |
| Date Received | 2012-11-14 |
| Date of Report | 2012-11-08 |
| Date of Event | 2012-11-08 |
| Date Facility Aware | 2012-11-08 |
| Report Date | 2012-11-08 |
| Date Reported to FDA | 2012-11-08 |
| Date Added to Maude | 2012-12-03 |
| 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 | 0 |
| 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 | BIOMET |
| Generic Name | BIOMET PEG BOARD |
| Product Code | FPS |
| Date Received | 2012-11-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-11-14 |