MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for FREER RH720 manufactured by Baxter Health Care Corp..
[10833]
Tip of septum knife (approximately 3/4 in. ) broke off during procedure for sinusitis. X-ray performed; piece was located and removed from patient during procedure. No apparent injury or increased length of stay as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 15847 |
| MDR Report Key | 15847 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-06-20 |
| Date of Event | 1994-06-09 |
| Date Facility Aware | 1994-06-09 |
| Report Date | 1994-06-18 |
| Date Reported to Mfgr | 1994-06-18 |
| Date Added to Maude | 1994-09-07 |
| 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 |
| Generic Name | FREER SEPTUM KNIFE |
| Product Code | EMF |
| Date Received | 1994-07-21 |
| Model Number | RH720 |
| Catalog Number | RH720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15780 |
| Manufacturer | BAXTER HEALTH CARE CORP. |
| Manufacturer Address | 1450 OWAUKEGAN RD. MCGRAW PARK IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-21 |