MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for FREER ELEVATOR RH 750 (PRINTED ON DEVICE) manufactured by Baxter V. Meuller.
[12915]
Performing septoplasty with use of freer elevator; end of freer elevator broke off during use in septal area; identified by x-ray. Patient initially under mac (monitored anesthesia care) for procedure, which became general anesthesia in order to remove piece of metal lodged in septal area. Patient required 23 hour observation in hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17397 |
| MDR Report Key | 17397 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-05-18 |
| Date of Event | 1994-05-13 |
| Date Facility Aware | 1994-05-18 |
| Report Date | 1994-05-18 |
| Date Added to Maude | 1994-11-03 |
| 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 | FREER ELEVATOR |
| Generic Name | FREER ELEVATOR |
| Product Code | KAD |
| Date Received | 1994-07-21 |
| Model Number | RH 750 |
| Catalog Number | (PRINTED ON DEVICE) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17325 |
| Manufacturer | BAXTER V. MEULLER |
| Manufacturer Address | 1425 LAKE COOK ROAD DEERFIELD IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1994-07-21 |