FDA Adverse Event
Malfunction
Summary report: N
ERGOLINE
MDR report key: 3833613
·
Received May 21, 2014
Report
- Report Number
- 9615023-2014-00001
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Date of Event
- May 16, 2014
- Report Date
- May 20, 2014
- Manufacturer
- JK PRODUCTS GMBH
- Product Code
- LEJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CLAIMANT ALLEGES BED CAUGHT FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301474 | ERGOLINE | ESPIRT | LEJ | JK PRODUCTS GMBH | 770 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |