MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-31 for * 051523 manufactured by Cardinal Health.
[2173798]
The head of the mallet broke off. Physician was using it, not sure how forcefully, but according to the staff, the head just fell off. The patient was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2235504 |
| MDR Report Key | 2235504 |
| Date Received | 2011-08-31 |
| Date of Report | 2011-08-31 |
| Date of Event | 2011-08-09 |
| Report Date | 2011-08-31 |
| Date Reported to FDA | 2011-08-31 |
| Date Added to Maude | 2011-09-06 |
| 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 | * |
| Generic Name | MALLET |
| Product Code | HXL |
| Date Received | 2011-08-31 |
| Model Number | 051523 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Age | 10 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN ROAD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-31 |