PROTEUS E.P. 2000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-18 for PROTEUS E.P. 2000 manufactured by Proteus Epilators, Inc..

Event Text Entries

[12688] Rptr had an electrolysis treatment done. The 5th treatment caused a 1-2 degree burn which left rptr to hide in her house for months. She saw her dr two days after and has also seen a plastic surgeon. The area of hair was changed due to this burn. It was a fine thin hair (brown in color) and now it is just like a man's beard. She is left with hoping the tissue will heal so she can do something about the hair. She has been told the equipment was set too high with too much heat.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1004085
MDR Report Key17867
Date Received1994-11-18
Date of Report1994-11-07
Date of Event1994-04-01
Date Added to Maude1994-11-21
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 FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePROTEUS E.P. 2000
Generic NameELECTROLYSIS MACHINE
Product CodeKCW
Date Received1994-11-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key17783
ManufacturerPROTEUS EPILATORS, INC.
Manufacturer AddressBELLINGHAM MA 02019 US


Patients

Patient NumberTreatmentOutcomeDate
131. Other; 2. Required No Informationntervention 1994-11-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.