FDA Adverse Event Malfunction Summary report: N

ENDO CATCH II

MDR report key: 3052106 · Received March 29, 2013

Report

Report Number
3052106
Event Type
Malfunction
Date Received
March 29, 2013
Date of Event
March 26, 2013
Report Date
March 29, 2013
Manufacturer
COVIDIEN
Product Code
GCJ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US

Narratives

Description of Event or Problem · 1

UPON OPENING BY THE DOCTOR, THE DEVICE BAG RIPPED. THE DEVICE WAS REMOVED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
129642 ENDO CATCH II SPECIMEN RETRIEVAL GCJ COVIDIEN * J1B0020

Patients

Seq Age Sex Outcome Treatment
1 58 YR