MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-10 for LUMARX IPL6800USAQ manufactured by Shaser, Inc.
[16633639]
User treated her face with ipl6800 hair removal device and sustained first and second degree burns, possibly resulting in permanent damage to her skin in the form of scarring. From the complaint: "consumer has lumarx and states she was burned to the point she had blisters on her face from it. Stated it was red after it was done woke up this morning blistered and black. Like curling iron burn. State she did not treat the same spot more than once. " ref mfr#: 3009088196-2015-00001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005855240-2015-00001 |
| MDR Report Key | 4698835 |
| Date Received | 2015-04-10 |
| Date of Report | 2015-04-10 |
| Date of Event | 2015-03-04 |
| Date Facility Aware | 2015-03-04 |
| Report Date | 2015-04-10 |
| Date Reported to FDA | 2015-04-10 |
| Date Reported to Mfgr | 2015-04-10 |
| Date Added to Maude | 2015-04-17 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 3001 DEMING WAY |
| Manufacturer City | MIDDLETON WI 535620000 |
| Manufacturer Country | US |
| Manufacturer Postal | 535620000 |
| Manufacturer G1 | SPECTRUM BRANDS INC. A DELAWARE CORPORATION |
| Manufacturer Street | 3001 DEMING WAY |
| Manufacturer City | MIDDLETON WI 53562000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53562 0000 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMARX |
| Generic Name | LIGHT BASED HAIR REMOVAL DEVICE |
| Product Code | ONF |
| Date Received | 2015-04-10 |
| Model Number | IPL6800USAQ |
| Catalog Number | IPL6800USAQ |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 4 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHASER, INC |
| Manufacturer Address | LEXINGTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-04-10 |