MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-27 for PHILIPS ADVANTAGE 808 140W 136408 manufactured by Philips Lighting B.v..
[372263]
In 2005 plc was contacted by its distributor who reported that several customers allegedly received injuries after using tanning devices allegedly equipped with sun tanning lamps manufactured by philips lighting company. The customers allegedly received cranberry colored stripes from their breasts to their knees resulting in some of the customers obtaining medical care. The report indicated that some of the customers claimed they sustained second degree burns. When contacted by plc, the salon owner advised that 3 customers claimed injuries, but has been unwilling to provide further info. It is reported that the tanning devices used by these customers were allegedly equipped by the salon operator with tanning lamps manufactured by philips lighting company. It is also reported that the lamps installed by the salon operator were manufactured by philips and were not compatible with the lamps specified by the tanning device manufacturer. It is also reported that the salon operator reset the tanning device timer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247247-2005-00001 |
| MDR Report Key | 609507 |
| Date Received | 2005-05-27 |
| Date of Report | 2005-05-26 |
| Date of Event | 2005-04-15 |
| Date Facility Aware | 2005-04-27 |
| Report Date | 2005-05-26 |
| Date Reported to FDA | 2005-05-26 |
| Date Reported to Mfgr | 2005-05-26 |
| Date Added to Maude | 2005-06-03 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS |
| Generic Name | SUN TANNING LAMPS |
| Product Code | IEH |
| Date Received | 2005-05-27 |
| Returned To Mfg | 2005-05-12 |
| Model Number | ADVANTAGE 808 140W |
| Catalog Number | 136408 |
| Lot Number | NOVEMBER 2004 |
| ID Number | 9279 773 80820 |
| Operator | OTHER |
| Device Availability | R |
| Device Age | 6 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 599317 |
| Manufacturer | PHILIPS LIGHTING B.V. |
| Manufacturer Address | ZWAANHOEFSTRAAT 2 PO BOX 1109 ROOSENDAAL NL 4700 BC |
| Baseline Brand Name | PHILIPS |
| Baseline Generic Name | SUN TANNING LAMPS |
| Baseline Model No | ADVANTAGE 808 1 |
| Baseline Catalog No | 136408 |
| Baseline ID | 9279 773 80820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-27 |