GALVANIC SPA II

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-23 for GALVANIC SPA II manufactured by Nu Skin.

Event Text Entries

[825785] After using the nuskin galvanic spa facial stimulator, the left side of my face felt numb and started tingling... Similar to novocaine wearing off after a dental procedure. I used the battery-operated device for a total of 10 mins - 5 mins on each side of my face -. Previously, i had used the device only on the right side to see if i could tell a difference compared with the untreated side. After 5 trials during a three week period, i then started using it on the left side of my face. During the procedure, i could feel slight "electrical shocks" on the left side of my face only. After using the device, i could feel numbness on the left side of my face as i washed it. After an hour, the numbness spread to my scalp, and areas of shooting pains developed on different areas of my face. First, the left temple area, then the left eye, forehead, ear and jaw. The right side of my face has remained unaffected. I read the instruction booklet again to see if anything i did could produce these symptoms. On page 15, there is a short warning about using the product if you "wear metal braces on your teeth, or have a metal implant. " i do have a hip replacement on my left hip, and have a porcelain covered metal crowns on the left side of my mouth, and thought one or both of those could have caused the problem. Dates of use: twenty-seven days in 2008. Diagnosis or reason for use: to tone skin and reduce appearance of wrinkles. Event abated after use stopped: no.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5005990
MDR Report Key1018962
Date Received2008-03-23
Date of Report2008-03-23
Date of Event2008-03-09
Date Added to Maude2008-04-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameGALVANIC SPA II
Generic NameGALVANIC SPA
Product CodeGZO
Date Received2008-03-23
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key987064
ManufacturerNU SKIN
Manufacturer AddressPROVO UT US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-03-23

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