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