FDA Adverse Event
Malfunction
Summary report: N
CARRIER WIRE FOR KRAUSE NASAL SNARE
MDR report key: 101842
·
Received June 26, 1997
Report
- Report Number
- 101842
- Event Type
- Malfunction
- Date Received
- June 26, 1997
- Date of Event
- May 5, 1997
- Report Date
- June 20, 1997
- Manufacturer
- ALLEGIANCE/MUELLER
- Product Code
- KBE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VT, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARRIER WIRE FOR KRAUSE NASAL SNARE | SURGICAL DEVICE - 6 5/8" | KBE | ALLEGIANCE/MUELLER | RH652-170 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Other |