HAIRMAX LASER COMB PROFESSIONAL 12

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5055332
MDR Report Key5001274
Date Received2015-08-05
Date of Report2015-08-05
Date of Event2015-04-01
Date Added to Maude2015-08-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHAIRMAX LASER COMB
Generic NameHAIRMAX LASER COMB
Product CodeOAP
Date Received2015-08-05
Model NumberPROFESSIONAL 12
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLEXINGTON


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-08-05

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