MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-05 for HAIRMAX LASER COMB PROFESSIONAL 12 manufactured by Lexington.
[22955389]
I have been using hairmax laser comb for 9 months and my hair is getting worse than ever. All my hair becomes so thin an increase hair loss, but hairmax asked me to keep using it. My dermatologist asked me to stop using it and my hair condition may be caused by the laser comb.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055332 |
| MDR Report Key | 5001274 |
| Date Received | 2015-08-05 |
| Date of Report | 2015-08-05 |
| Date of Event | 2015-04-01 |
| Date Added to Maude | 2015-08-13 |
| 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 | HAIRMAX LASER COMB |
| Generic Name | HAIRMAX LASER COMB |
| Product Code | OAP |
| Date Received | 2015-08-05 |
| Model Number | PROFESSIONAL 12 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEXINGTON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-05 |