MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-03 for FREER ELEVATOR BY V. MUELLER RH 750 * manufactured by Cardinal/v. Mueller Health Care.
[333225]
While md manipulating internal nose with "freer" elevator, instrument broke off in nose - partially. Portion of instrument retrieved in pt's throat. No known injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028623 |
| MDR Report Key | 464544 |
| Date Received | 2003-06-03 |
| Date of Report | 2003-06-03 |
| Date of Event | 2003-05-07 |
| Date Added to Maude | 2003-06-10 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREER ELEVATOR BY V. MUELLER |
| Generic Name | NASAL FRACTURE BONE ELEVATOR |
| Product Code | GEG |
| Date Received | 2003-06-03 |
| Model Number | RH 750 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 453466 |
| Manufacturer | CARDINAL/V. MUELLER HEALTH CARE |
| Manufacturer Address | 1240 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-06-03 |