FDA Adverse Event Injury Summary report: N

LIFE PAK

MDR report key: 110403 · Received July 30, 1997

Report

Report Number
MW4001900
Event Type
Injury
Date Received
July 30, 1997
Date of Event
July 8, 1997
Report Date
July 25, 1997
Manufacturer
PHYSIO-CONTROL CORP.
Product Code
LDD
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
ATTORNEY

Narratives

Description of Event or Problem · 1

RPTR RECENTLY SUBMITTED A VOLUNTARY MEDWATCH REPORT, DATED 7/25/1997, WITH A COPY TO THE MFR. SINCE THEN RPTR HAS DISCOVERED THAT THE SERIAL NUMBER ON THE REPORT WAS INCORRECT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LIFE PAK DEFIBRILLATOR LDD PHYSIO-CONTROL CORP. LP-6D *

Patients

Seq Age Sex Outcome Treatment
1 6 MO Required Intervention