MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-14 for ULTIMA 9 HAIR GROWTH manufactured by Lexington International Llc.
[28808233]
Used hairmax ultima 9 hair growth laser comb. I broke out on my scalp with shingles after 2 treatments. My wife's hair is falling out and her scalp itches constantly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057214 |
| MDR Report Key | 5161787 |
| Date Received | 2015-10-14 |
| Date of Report | 2015-10-14 |
| Date of Event | 2015-10-07 |
| Date Added to Maude | 2015-10-20 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 | ULTIMA 9 HAIR GROWTH |
| Generic Name | LASER COMB |
| Product Code | OAP |
| Date Received | 2015-10-14 |
| Model Number | ULTIMA 9 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | LEXINGTON INTERNATIONAL LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-14 |