MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-09 for NO BOUNCE MALLET * 740042 manufactured by Biomet, Inc..
[17529801]
A sterile mallet broke open during a surgical procedure. The interior contents of pellets and powder spilled onto the sterile field into the wound. This was immediately isolated. Extra antibiotics were given to the patient. X-rays were taken and read as negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1476612 |
| MDR Report Key | 1476612 |
| Date Received | 2009-09-09 |
| Date of Report | 2009-09-09 |
| Date of Event | 2009-09-01 |
| Report Date | 2009-09-09 |
| Date Reported to FDA | 2009-09-09 |
| Date Added to Maude | 2009-09-18 |
| 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 |
| 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 | NO BOUNCE MALLET |
| Generic Name | INSTRUMENT, MALLET |
| Product Code | HXL |
| Date Received | 2009-09-09 |
| Model Number | * |
| Catalog Number | 740042 |
| Lot Number | 124080 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | 56 EAST BELL DRIVE WARSAW IN 46582698 US 46582 6989 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-09 |