TE SYSTEM TE-629 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-14 for TE SYSTEM TE-629 UNKNOWN manufactured by American Hair Removal System.

Event Text Entries

[22174558] Rptr was giving a treatment using the device. After 10 to 12 mins she experienced a metallic taste which lasted a few days. She called the distributor who said she had heard of this type of complaint but had no idea how this reaction occurred. Rptr has metal caps in her mouth and believes that perhaps this is what caused the reaction. Rptr also experienced stomach problems (nausea and increased acid), dizziness and numbness of her face. The increased acid, she understands, is due to metal oxidation under mild electrical field (ionization). Rptr was advised to drink water and milk (after antacids did not work) and this was helpful. In april and may rptr obtained more clients and increased her working hrs from 1 hr per week to approx 5-6 hrs per week and became very weak with itching of her back/irritation of the skin of her back. She was seen by a dermatologist who said it was "protein deposits. " she was given medication but itch stopped after rptr cancelled her clients. She is feeling better now but still has some residual numbness of the face. Rptr also had 3 clients who experienced electric shock while being treated. If rptr was doing a treatment on client with metal caps in the mouth she felt even worse during the treatment. According to rptr, the transdermal electrolysis device has 5 to 6 times more current than electrolysis devices using needles.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1009709
MDR Report Key35255
Date Received1996-08-14
Date of Report1996-08-14
Date of Event1995-12-01
Date Added to Maude1996-08-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTE SYSTEM
Generic NameTRANSDERMAL ELECTROLYSIS PERMANENT HAIR REMOVAL SYSTEM
Product CodeKCX
Date Received1996-08-14
Model NumberTE-629
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorOTHER
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key36674
ManufacturerAMERICAN HAIR REMOVAL SYSTEM
Manufacturer Address140 TURNER ST SOUTHERN PINES NC 28378 US


Patients

Patient NumberTreatmentOutcomeDate
10 1996-08-14

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