FDA Adverse Event
Malfunction
Summary report: N
SUNDASH
MDR report key: 2563074
·
Received April 16, 2012
Report
- Report Number
- 2311923-2012-00013
- Event Type
- Malfunction
- Date Received
- April 16, 2012
- Date of Event
- February 6, 2007
- Report Date
- April 16, 2012
- Manufacturer
- JK PRODUCTS & SERVICES, INC.
- Product Code
- LEJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
CLAIMANT ALLEGES INSUREDS TANNING BED WAS DEFECTIVE WHICH RESULTED IN AN ELECTRICAL FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUNDASH | RADIUS 252 | LEJ | JK PRODUCTS & SERVICES, INC. | SR 252 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |