MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-05 for REGROW MD HAIRMAX LASER 272 LASER272-KIT manufactured by Lexington Intl, Llc.
[138066037]
Started using regrow laser cap by hairmax with laser 272 in (b)(6) 2018 to improve hair growth because i have female pattern hair loss. I have not seen any of the promised benefits, not even a progress in that direction and only side effects so far for 4 months. The worst side effects are itchy, oily, flaky scalp and possibly associated shedding of tiny hairs, with no signs of improvement so far. Even though hair shedding is a well-known of any hair growth treatment, it is not added as a side effect in the user manual or the device box. Fda has not asked them too either, strange. This has severely impacted my hair quality and overall psyche. More importance has to be given to this and fda has to intervene because this device is regulated by fda as class ii.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084668 |
| MDR Report Key | 8394149 |
| Date Received | 2019-03-05 |
| Date of Report | 2019-03-02 |
| Date of Event | 2018-11-05 |
| Date Added to Maude | 2019-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 | 3 |
| Brand Name | REGROW MD HAIRMAX LASER 272 |
| Generic Name | LASER, COMB, HAIR |
| Product Code | OAP |
| Date Received | 2019-03-05 |
| Catalog Number | LASER272-KIT |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEXINGTON INTL, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-05 |