FDA Adverse Event
Malfunction
Summary report: N
SUNDASH
MDR report key: 2563076
·
Received April 16, 2012
Report
- Report Number
- 2311923-2012-00011
- Event Type
- Malfunction
- Date Received
- April 16, 2012
- Date of Event
- November 21, 2006
- Report Date
- April 16, 2012
- Manufacturer
- JK PRODUCTS & SERVICES, INC.
- Product Code
- LEJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
CLAIMANT ALLEGES SHE WAS INJURED WHEN TANNING BED COVER CAME DOWN AND HIT HER ON HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUNDASH | 232 | LEJ | JK PRODUCTS & SERVICES, INC. | SUNDASH 232 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |