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 |