FDA Adverse Event
Malfunction
Summary report: N
DURACELL PRO
MDR report key: 512502
·
Received February 6, 2004
Report
- Report Number
- MW1030986
- Event Type
- Malfunction
- Date Received
- February 6, 2004
- Date of Event
- January 26, 2004
- Report Date
- February 6, 2004
- Manufacturer
- *
- Product Code
- FCO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AR, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A DURACELL PRO 9 VOLT BATTERY WAS LYING ON A DESK IN THE CARDIAC REHABILITATION UNIT. THERE WAS A LOUD SOUND THAT SOUNDED LIKE AN EXPLOSION. THE BOTTOM COVERING OF THE BATTERY HAD BEEN BLOWN OFF AND 2 METAL CYLINDERS WERE PROJECTING OUT OF THE BOTTOM OF THE BATTERY. THERE WAS NO WATER OR HEAT AROUND THE BATTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURACELL PRO | 9 VOLT BATTERY | FCO | * | * | * | |
| 2 | DURACELL PRO | 9 VOLT BATTERY | FCO | * | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |