BEUDAMED
    FDA Adverse Event Other Summary report: N

    RS-LB LOW BACK CONDUCTIVE GARMENT

    MDR report key: 1719474 · Received March 29, 2010

    Report

    Report Number
    1644243-2010-00001
    Event Type
    Other
    Date Received
    March 29, 2010
    Date of Event
    March 29, 2008
    Report Date
    April 25, 2008
    Manufacturer
    RS MEDICAL
    Product Code
    GZJ
    PMA / PMN Number
    K090951
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RS MEDICAL RESPONSE TO FDA'S INQUIRY ON (B)(4) DATED (B)(4) 2009. THE REPORTED EVENT WAS NOT INITIALLY FILED AS AN MDR AS THE ATTENDING PHYSICIAN DESCRIBED THE RESULTING DISCOLORATION AS COSMETIC IN NATURE. TESTING OF A REP STIMULATOR AT A PULSE INTENSITY OF 5 WAS DETERMINED TO RESULT IN A LEVEL BELOW THE THRESHOLD OF POWER DENSITY REQUIRED TO DAMAGE SKIN WITH A 2" SQUARE ELECTRODE PAD. THE REPORTED SKIN DAMAGE DID NOT APPEAR TO BE ELECTRICAL IN ORIGIN AND WAS DEEMED TO HAVE RESULTED FROM SOME SKIN HYPERSENSITIVITY THE PT HAD DEVELOPED. MDR FILED (B)(4) 2010.

    Description of Event or Problem · 1

    PT REPORTED SUFFERING SKIN BURNS FROM USE OF TENS STIMULATOR AND CONDUCTIVE GARMENT AFTER ONE USE FOR FOUR HOURS AT A MID LEVEL INTENSITY SETTING (5). SHE FELT NO PAIN BUT WHEN GARMENT WAS REMOVED, THE PT NOTICED BLISTERS. SCARRING OCCURRED ON ALL FOUR PLACES WHERE ELECTRODE PADS TOUCHED SKIN. PT WAS PRESCRIBED AN OINTMENT AND WAS REFERRED TO A DERMATOLOGIST. PT EARLIER REPORTED RECEIVING A RASH, SKIN IRRITATION FROM 2" ROUND ELECTRODE PADS PRIOR TO RECEIVING THE CONDUCTIVE GARMENT. PT RECEIVED SENSITIVE SKIN PADS PRIOR TO RECEIVING GARMENT. PT FILED AN MDR REPORT ((B)(4)) BASED ON THE COMPLAINT. SUBSEQUENT FOLLOW-UP INFO SUPPLIED BY THE PT SHOWED PHOTOGRAPHIC EVIDENCE OF HYPERPIGMENTATION ON AREAS OF THE BACK RELATED TO ELECTRODE PAD PLACEMENT POSSIBLY RESULTING FROM A CONTACT DERMATITIS. THE RESULTING EFFECT APPEARED TO BE COSMETIC IN NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RS-LB LOW BACK CONDUCTIVE GARMENT LOW BACK CONDUCTIVE GARMENT GZJ RS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other