MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-02 for HAIRMAX LASER BRUSH manufactured by Lexington International, Llc.
[16729876]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021578 |
| MDR Report Key | 2190806 |
| Date Received | 2011-08-02 |
| Date of Report | 2011-08-02 |
| Date of Event | 2009-02-10 |
| Date Added to Maude | 2011-08-09 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAIRMAX LASER BRUSH |
| Generic Name | LASER BRUSH |
| Product Code | OAP |
| Date Received | 2011-08-02 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEXINGTON INTERNATIONAL, LLC |
| Manufacturer Address | 777 YAMATO RD., STE. 105 BOCA RATON FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-02 |