MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-12 for IPL HAIRE REMOVER manufactured by Unk.
[89249304]
My wife has been going for laser hair treatment at radiance light systems, (b)(6). On (b)(6) 2017 when she went for laser treatment they literally burnt her skin i. E. On right hand there are (b)(6) burnt spots, left hand, (b)(6) burnt spots, right leg, (b)(6) burn spots, and left leg, (b)(6) burnt spots. I am going to upload lots of pictures. If i cannot attach it i have photos and video for me to upload or attach to this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072734 |
| MDR Report Key | 6943982 |
| Date Received | 2017-10-12 |
| Date of Report | 2017-10-10 |
| Date of Event | 2017-10-07 |
| Date Added to Maude | 2017-10-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | IPL HAIRE REMOVER |
| Generic Name | POWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT |
| Product Code | ONF |
| Date Received | 2017-10-12 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-12 |