FDA Adverse Event Malfunction Summary report: N

6000032-1998-00023

MDR report key: 148662 · Received February 9, 1998

Report

Report Number
6000032-1998-00023
Event Type
Malfunction
Date Received
February 9, 1998
Date of Event
January 8, 1997
Product Code
GZB
Report Source
Manufacturer report

Narratives

Description of Event or Problem · 1

AFTER SEVERAL ATTEMPTS, MFR WAS UNABLE TO OBTAIN MORE INFO ABOUT THE REPORTED EVENT FROM THE USER FACILITY, AND IS THEREFORE UNABLE TO VERIFY WHETHER THERE WAS ANY TYPE OF INJURY AS A RESULT OF THE ALLEGED DEVICE MALFUNCTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GZB 3487A L41700

Patients

Seq Age Sex Outcome Treatment
1