FDA Adverse Event
Injury
Summary report: N
HAIRMAX LASER COMB
MDR report key: 5001274
·
Received August 5, 2015
Report
- Report Number
- MW5055332
- Event Type
- Injury
- Date Received
- August 5, 2015
- Date of Event
- April 1, 2015
- Report Date
- August 5, 2015
- Manufacturer
- LEXINGTON
- Product Code
- OAP
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517615 | HAIRMAX LASER COMB | HAIRMAX LASER COMB | OAP | LEXINGTON | PROFESSIONAL 12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |