HAIRMAX LASER BRUSH

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5021578
MDR Report Key2190806
Date Received2011-08-02
Date of Report2011-08-02
Date of Event2009-02-10
Date Added to Maude2011-08-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHAIRMAX LASER BRUSH
Generic NameLASER BRUSH
Product CodeOAP
Date Received2011-08-02
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerLEXINGTON INTERNATIONAL, LLC
Manufacturer Address777 YAMATO RD., STE. 105 BOCA RATON FL 33431 US 33431


Patients

Patient NumberTreatmentOutcomeDate
10 2011-08-02

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