MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for SOFT IMPACT MALLET WITH WEIDMAN SILICONE HANDLE 7832 manufactured by Innomed Orthopedic Instruments.
[102497411]
Black tip at the end of mallet came apart during a case and had excessive bioburden. Mallet was removed from service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075853 |
| MDR Report Key | 7337485 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-12 |
| Date of Event | 2018-03-05 |
| Date Added to Maude | 2018-03-14 |
| 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 |
| 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 | 0 |
| Brand Name | SOFT IMPACT MALLET WITH WEIDMAN SILICONE HANDLE |
| Generic Name | SOFT IMPACT MALLET WITH WEIDMAN SILICONE HANDLE |
| Product Code | HXL |
| Date Received | 2018-03-13 |
| Model Number | 7832 |
| Lot Number | L#0815MT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOMED ORTHOPEDIC INSTRUMENTS |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-13 |