MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-03 for SOUNDTEC IMPLANT * manufactured by Soundtec Inc.
[384715]
Implant of soundtec ear prosthesis was done 2002. The pt required surgery 2004 to have the prosthesis removed due to it malfuncting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 563248 |
| MDR Report Key | 563248 |
| Date Received | 2005-01-03 |
| Date of Report | 2004-12-20 |
| Date of Event | 2004-12-15 |
| Date Facility Aware | 2004-12-15 |
| Report Date | 2004-12-20 |
| Date Reported to Mfgr | 2004-12-20 |
| Date Added to Maude | 2005-01-06 |
| 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 | 3 |
| 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 | SOUNDTEC IMPLANT |
| Generic Name | EAR PROSTHESIS |
| Product Code | FZD |
| Date Received | 2005-01-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | PART 300-0038-001 |
| Operator | NOT APPLICABLE |
| Device Availability | * |
| Device Age | 2.5 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 552976 |
| Manufacturer | SOUNDTEC INC |
| Manufacturer Address | 2601 NORHTWEST EXPRESSWAY ST OKLAHOMA CITY OK * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-01-03 |