MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-17 for KURZ * 1004020 manufactured by Kurz Medical.
[1957303]
During placement for left tympanoplasty, possible vision ossiculoplasty, and mastoidectomy placement of ear implant, the doctor was unable to crimp implant. The device was replaced with another implant, which was properly placed and crimped. The patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032237 |
| MDR Report Key | 2032237 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-03-17 |
| Date of Event | 2011-03-10 |
| Report Date | 2011-03-17 |
| Date Reported to FDA | 2011-03-17 |
| Date Added to Maude | 2011-03-29 |
| 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 | RISK MANAGER |
| 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 | KURZ |
| Generic Name | PROSTHESIS, EAR |
| Product Code | ETB |
| Date Received | 2011-03-17 |
| Model Number | * |
| Catalog Number | 1004020 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KURZ MEDICAL |
| Manufacturer Address | 320 DECKER DR. IRVING TX 75062 US 75062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-17 |