MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-26 for CARRIER WIRE FOR KRAUSE NASAL SNARE RH652-170 manufactured by Allegiance/mueller.
[65372]
Carrier wire for krause nasal snare broke during surgery. Device had been assembled properly and was in the hands of an experienced surgeon experienced in use of device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 101842 |
| MDR Report Key | 101842 |
| Date Received | 1997-06-26 |
| Date of Report | 1997-06-20 |
| Date of Event | 1997-05-05 |
| Date Facility Aware | 1997-05-05 |
| Report Date | 1997-06-20 |
| Date Added to Maude | 1997-07-02 |
| 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 |
| 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 | CARRIER WIRE FOR KRAUSE NASAL SNARE |
| Generic Name | SURGICAL DEVICE - 6 5/8" |
| Product Code | KBE |
| Date Received | 1997-06-26 |
| Model Number | RH652-170 |
| Catalog Number | RH652-170 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 100228 |
| Manufacturer | ALLEGIANCE/MUELLER |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGRAW PARK IL 60085 US |
| Baseline Brand Name | KRAUSE WIRE CARRIER |
| Baseline Generic Name | WIRE CARRIER |
| Baseline Model No | RH652-170 |
| Baseline Catalog No | RH652-170 |
| Baseline ID | NA |
| Baseline Device Family | WIRE CARRIER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-06-26 |