MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-06 for RICHARDS * 140186 manufactured by Smith Nephew Richards.
[39767]
During a stapedectomy case the physician was given device. Physician stated that prosthesis was defective because the hook was "too closed" to properly affix to the middle ear structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 67891 |
| MDR Report Key | 67891 |
| Date Received | 1997-01-06 |
| Date of Report | 1996-10-23 |
| Date of Event | 1996-10-16 |
| Date Facility Aware | 1996-10-16 |
| Report Date | 1996-10-23 |
| Date Added to Maude | 1997-02-12 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | RICHARDS |
| Generic Name | HOUSE-TYPE WIRE LOOP |
| Product Code | JYQ |
| Date Received | 1997-01-06 |
| Model Number | * |
| Catalog Number | 140186 |
| Lot Number | 4085175464 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 67899 |
| Manufacturer | SMITH NEPHEW RICHARDS |
| Manufacturer Address | 1450 BROOK RD MEMPHIS TN 38116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-06 |