FDA Adverse Event
Other
Summary report: N
HAIRMAX LASER BRUSH
MDR report key: 2190806
·
Received August 2, 2011
Report
- Report Number
- MW5021578
- Event Type
- Other
- Date Received
- August 2, 2011
- Date of Event
- February 10, 2009
- Report Date
- August 2, 2011
- Manufacturer
- LEXINGTON INTERNATIONAL, LLC
- Product Code
- OAP
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
REPORTER STATED THAT HE HAS BEEN USING THE HAIRMAX LASER BRUSH SINCE (B)(6) 2009 AND HASN'T NOTICED ANY HAIR GROWTH. REPORTER STATED THAT ACCORDING TO THE BOX, HE SHOULD HAVE NOTICED HAIR GROWTH WITHIN 12-14 WEEKS. REPORTER ALSO STATED THAT CONSUMER REPORTS DATED (B)(6) 2010, DIDN'T MENTION LASER BRUSH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAIRMAX LASER BRUSH | LASER BRUSH | OAP | LEXINGTON INTERNATIONAL, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |