FDA Adverse Event
Malfunction
Summary report: N
KANG EPMP ADP W/ 4 PWR ADP PLG
MDR report key: 2963033
·
Received January 24, 2013
Report
- Report Number
- 1282497-2013-00001
- Event Type
- Malfunction
- Date Received
- January 24, 2013
- Report Date
- December 31, 2012
- Manufacturer
- COVIDIEN
- Product Code
- LZH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A KANGAROO E-PUMP ADAPTER. THE CUSTOMER REPORTS THAT THE ADAPTER PIECE OF THE POWER CORD THAT ATTACHES TO THE WALL BEGAN SMOKING. THERE IS A SMALL HOLE IN THE ADAPTER WHERE IT BURNED THROUGH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34871 | KANG EPMP ADP W/ 4 PWR ADP PLG | POWER CORD | LZH | COVIDIEN | 382491 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |