BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 22693802 · Received August 2, 2025

    Report

    Report Number
    3010402752-2025-00002
    Event Type
    Malfunction
    Date Received
    August 2, 2025
    Report Date
    May 31, 2023
    Manufacturer
    HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
    Product Code
    GYB
    UDI-DI
    00092237623756
    PMA / PMN Number
    K121719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE CAUSE: AFTER INQUIRING WITH THE DISTRIBUTOR, IT WAS LEARNED THAT A USER HAD A BURN ON THEIR SKIN IN THE PAST, WHICH HAD HEALED MANY YEARS AGO. WHEN USING THE PRODUCT IN ACCORDANCE WITH THE INSTRUCTIONS, THEY FELT A BURNING SENSATION AND STOPPED USING IT. NO INJURY WAS CAUSED. THE USER HAD CONSULTED THE US DISTRIBUTOR. AFTER INVESTIGATION: 1. THE PRODUCT VERIFICATION REPORT WAS CHECKED. THIS MODEL OF PRODUCT HAS PASSED THE IEC60601-2-10:2016 STANDARD TEST (REPORT NO.: (B)(4), REPORT DATE: 2023-02-10), AND THE OUTPUT ENERGY OF THE PRODUCT MEETS SAFETY REQUIREMENTS. 2. THE PRODUCTION BATCH RECORD OF ORDER (B)(4) (N0: (B)(4)) WAS CHECKED. THIS BATCH OF PRODUCTION COMPLIES WITH PRODUCT SPECIFICATION REQUIREMENTS. 3. THE PRODUCT DESIGN AND PRODUCTION BOTH MEET THE STANDARDS AND QUALITY REQUIREMENTS. REGARDING THE REMINDER OF DISCOMFORT DURING USE, IT HAS BEEN MENTIONED IN THE TENS 7000 RECHARGEABLE USER MANUAL V1.1. 4. AS THE USER'S INJURED AREA HAD HEALED FOR MANY YEARS, THEY WERE NOT AWARE THAT THE HEALED SKIN WAS MORE SENSITIVE THAN NORMAL SKIN. THEREFORE, THEY USED THE PRODUCT WITHOUT CONSULTING A DOCTOR. 5. NO SUCH PROBLEM REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT IN PREVIOUS SALES. ACTION: 1. SINCE THE PRODUCT DESIGN MEETS THE STANDARD REQUIREMENTS AND THE PRODUCTION COMPLIES WITH THE SPECIFICATION REQUIREMENTS, NO CAPA IS NECESSARY. 2. THE MARKETING DEPARTMENT WILL CONTACT THE DISTRIBUTORS, ASKING THEM TO CONTACT THE USER FOR AN EXPLANATION. THEY SHOULD INFORM THE USER THAT THE SKIN THAT HAS HEALED FROM AN INJURY IS SENSITIVE AND IS NOT SUITABLE FOR USING THE TENS PRODUCT AT THIS LOCATION.

    Description of Event or Problem · 0

    CUSTOMER SAID HE HAS BURN/BLACK MARKS WHERE THE ELECTRODES WERE ON HIS BODY. NO DOCTOR APPROVAL WAS RECEIVED AS THIS WAS AN OTC DEVICE AND PREVIOUS BURNS IS NOT LISTED AS A CONTRAINDICATION. CUSTOMER SAID I HAVE USED PREVIOUS ELECTRODES AND TENS UNITS WITHOUT ISSUE. PER TWF: PRE-EXISTING CONDITIONS IS "PREVIOUS BURNS, HEALED, AT AREA". BIPHASIC RECTANGULAR, MODULATED WAVEFORM - 100 HZ @ 300 S PULSE WIDTH USING 2X2" SELF ADHESIVE ELECTRODES ON LEFT UPPER ARM 5" APART, 2 IN TOTAL. WHEN ASKED IF NEW OR USED, CUSTOMER STATES "YES". STATES BURNS APPEARED IMMEDIATELY, REMOVED DUE TO SENSATION OF BURNS, ON GOING.HE DID SEEK MEDICAL ATTENTION. STATES ELECTRODES USED "0" TIMES PREVIOUSLY. STATES ELECTRODES STORED IN THE ORIGINAL PACKAGING BETWEEN 41-86F AND 40-70% HUMIDITY. ROOM AIR. STATES ELECTRODES WERE.5" APART, NO KNOWN ALLERGIES. 300US WIDTH, 100HZ RATE. USING TENS 7000 BRAND ELECTRODES. HAS NOT TRIED NEW LEADS, SHOW NO DAMAGE. THE ORIGINAL BURNS WERE CAUSED BY A HOUSE FIRE IN 2013.THE TISSUE, AT TIME OF USE, WAS HEALED AND HAS BEEN FOR ~ 7 YEARS. 2. WERE THE ELECTRODES 5" APART OR.5"? 0.5." 3. WERE THE ELECTRODES 100% ADHERED TO THE SKIN WHEN YOU WERE USING THEM? YES.USER MANUAL ATTACHED: PAGE19, BOTTOM OF PAGE WARNING: TO AVOID AN ELECTRICAL SHORT, NEVER PUT TWO ELECTRODE PADS TOGETHER. THEY MUST BE AT LEAST 2" BUT NOT MORE THAN 6" APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205456 COMPASS HEALTH BRANDS TENS 7000 RECHARGEABLE GYB HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED DT7303 P026-220818155 00092237623756

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male