FDA Adverse Event
Malfunction
Summary report: N
SUNDASH 332
MDR report key: 2563083
·
Received April 16, 2012
Report
- Report Number
- 2311923-2012-00007
- Event Type
- Malfunction
- Date Received
- April 16, 2012
- Date of Event
- February 6, 2009
- Report Date
- April 16, 2012
- Manufacturer
- JK PRODUCTS & SERVICES INC.
- Product Code
- LEJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
CLAIMANT ALLEGES THE TANNING BED CANOPY FELL FROM THE OPEN POSITION, STRIKING HER AND CAUSING INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUNDASH 332 | SUNDASH 332 | LEJ | JK PRODUCTS & SERVICES INC. | SUNDASH 332 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |