FDA Adverse Event Summary report: N

TE SYSTEM

MDR report key: 35255 · Received August 14, 1996

Report

Report Number
MW1009709
Date Received
August 14, 1996
Date of Event
December 1, 1995
Report Date
August 14, 1996
Manufacturer
AMERICAN HAIR REMOVAL SYSTEM
Product Code
KCX
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TE SYSTEM TRANSDERMAL ELECTROLYSIS PERMANENT HAIR REMOVAL SYSTEM KCX AMERICAN HAIR REMOVAL SYSTEM TE-629 UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 51 YR