MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-06-29 for RIGHT ANGLE PICK UNKNOWN manufactured by V. Mueller Div. Baxter Healthcare Corp..
[25750]
The tip of the instrument broke off in the inner ear during surgery. The broken piece could not be retrieved from the ear. The incident did not cause permanent impairment of a body function or structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 34730 |
| MDR Report Key | 34730 |
| Date Received | 1996-06-29 |
| Date of Report | 1996-06-24 |
| Date of Event | 1996-06-18 |
| Date Facility Aware | 1996-06-18 |
| Report Date | 1996-06-24 |
| Date Reported to FDA | 1996-06-24 |
| Date Reported to Mfgr | 1996-06-24 |
| Date Added to Maude | 1996-08-01 |
| 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 | RIGHT ANGLE PICK |
| Generic Name | RIGHT ANGLE PICK |
| Product Code | JYT |
| Date Received | 1996-06-29 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 36110 |
| Manufacturer | V. MUELLER DIV. BAXTER HEALTHCARE CORP. |
| Manufacturer Address | 1425 LAKE COOK RD DEARFIELD IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-06-29 |