MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-02 for V. MUELLER * AU 12950 manufactured by Allegiance V. Mueller.
[67325]
While using mccabe knife, removing tragus graft from graft smasher, the end of knife broke off. Piece of knife was removed from surgical field. No injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 107629 |
| MDR Report Key | 107629 |
| Date Received | 1997-07-02 |
| Date of Report | 1997-05-08 |
| Date of Event | 1997-03-26 |
| Date Facility Aware | 1997-03-26 |
| Report Date | 1997-05-08 |
| Date Reported to Mfgr | 1997-05-08 |
| Date Added to Maude | 1997-07-25 |
| 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 | V. MUELLER |
| Generic Name | MCCABE |
| Product Code | EMF |
| Date Received | 1997-07-02 |
| Returned To Mfg | 1997-05-08 |
| Model Number | * |
| Catalog Number | AU 12950 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 105788 |
| Manufacturer | ALLEGIANCE V. MUELLER |
| Manufacturer Address | 1425 LAKECOOK RD DEERFIELD IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-02 |