MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-21 for UWE P90C P90 COMBO manufactured by Uwe Light Gmbh.
[70750819]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70750820]
Tanning device - during normal use it appears electrical short generated an ignition by one or more lamps and has caused the equipment to ignite causing the material to burn in the canopy operating area within the unit. The operating staff using the fire extinguisher put out the flames. Fire department called in to make inspections. No injury occured to user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000122259-2017-10002 |
| MDR Report Key | 6420904 |
| Date Received | 2017-03-21 |
| Date of Report | 2017-03-21 |
| Date of Event | 2016-11-15 |
| Date Facility Aware | 2016-11-15 |
| Report Date | 2017-03-21 |
| Date Reported to FDA | 2017-03-21 |
| Date Added to Maude | 2017-03-21 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UWE |
| Generic Name | SUNTANNING BED |
| Product Code | RAB |
| Date Received | 2017-03-21 |
| Model Number | P90C |
| Catalog Number | P90 COMBO |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UWE LIGHT GMBH |
| Manufacturer Address | BUCHSTRABE 82 SCHWABISCH GMUND, 73525 GM 73525 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-21 |