FDA Adverse Event
Malfunction
Summary report: N
KBL TOWER PURE ENERGY
MDR report key: 6459742
·
Received April 5, 2017
Report
- Report Number
- 3006116732-2017-00002
- Event Type
- Malfunction
- Date Received
- April 5, 2017
- Date of Event
- February 7, 2017
- Report Date
- March 29, 2017
- Manufacturer
- KBL AG
- Product Code
- LEJ
- PMA / PMN Number
- K151962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CLAIMANT ALLEGES SUNBED DEVELOPED SMOKE AFTER USE AND CAUGHT FIRE.
Description of Event or Problem · 1
CLAIMANT ALLEGES SUNBED DEVELOPED SMOKE AFTER USE AND CAUGHT FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244123 | KBL TOWER PURE ENERGY | SUNLAMP PRODUCT | LEJ | KBL AG | TOWER PURE ENERGY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |