MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-17 for 3 MM RICHARDS 90 DEGREE ANGLE EAR PICK OR HOOK 13-0041 manufactured by Smith And Nephew Richards.
[7921]
During left stapedectomy the angle portion of the 90 degree angle ear pick broke off in the pt's ear. The instrument piece was left in the area as the surgeon felt that to try to remove it would pose a further danger to the pt. The instrument was sent to ecri for independent analysis and the mfr was notified of the incident. The size of the ear pick was 3 mm. The pt's diagnosis was bilateral otosclerosis/hearing loss pre-operatively. The pt was informed of the occurrence by the physician and discharged on 12/16/93 with follow-up to be in the physician's office. (the piece was left because the md felt trying to remove it could possibly cause permanent damage to the inner ear. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10910 |
| MDR Report Key | 10910 |
| Date Received | 1993-12-17 |
| Date of Report | 1993-12-17 |
| Date of Event | 1993-12-15 |
| Date Facility Aware | 1993-12-15 |
| Report Date | 1993-12-17 |
| Date Reported to FDA | 1993-12-17 |
| Date Reported to Mfgr | 1993-12-17 |
| Date Added to Maude | 1994-01-11 |
| 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 | 3 MM RICHARDS 90 DEGREE ANGLE EAR PICK OR HOOK |
| Generic Name | EAR PICK OR HOOK |
| Product Code | JYT |
| Date Received | 1993-12-17 |
| Model Number | 13-0041 |
| Catalog Number | 13-0041 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10910 |
| Manufacturer | SMITH AND NEPHEW RICHARDS |
| Manufacturer Address | MEMPHIS TN 38116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-12-17 |