LASER HAIR REMOVAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for LASER HAIR REMOVAL manufactured by Unk.

Event Text Entries

[63237635] I got a serious yeast infection right after bikini area laser hair removal treatment. I feel it is complete relatedness to the laser. I even infected my husband.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5066896
MDR Report Key6202798
Date Received2016-12-22
Date of Report2016-12-22
Date of Event2016-12-16
Date Added to Maude2016-12-23
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 NameLASER HAIR REMOVAL
Generic NameLASER HAIR REMOVAL
Product CodeOHT
Date Received2016-12-22
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2016-12-22

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