FDA Adverse Event
Other
Summary report: N
SUNDASH
MDR report key: 3982912
·
Received July 10, 2014
Report
- Report Number
- 2311923-2014-00005
- Event Type
- Other
- Date Received
- July 10, 2014
- Date of Event
- May 6, 2013
- Report Date
- July 9, 2014
- Manufacturer
- JK PRODUCTS & SERVICES, INC.
- Product Code
- LEJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER TANNED FOR AN HOUR, WHICH IS FORTY MINUTES LONGER THAN WHAT THE LISTED EXPOSURE TIME ON THE EXPOSURE LABEL FOR THE TANNING BED.
Description of Event or Problem · 1
WIRING IN POWER HARNESS SHORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405305 | SUNDASH | ENDURANCE | LEJ | JK PRODUCTS & SERVICES, INC. | 424 SL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |