BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRENGTH TAPE

    MDR report key: 6125771 · Received November 23, 2016

    Report

    Report Number
    3012316249-2016-00002
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 23, 2016
    Manufacturer
    SUZHOU SUNMED CO LTD
    Product Code
    HXT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CALLED ON (B)(6) 2016 TO REPORT HAVING AN ALLERGIC REACTION TO A STRENGTHTAPE SHOULDER KIT, ITEM NUMBER 6300-SHLDR. THE CUSTOMER NOTICED THE IRRITATION WITHIN 2 HOURS OF USING THE TAPE. THE CUSTOMER HAD A SIMILAR REACTION TO THE ADHESIVE IN A NICOTINE PATCH ABOUT 8 YEARS PRIOR TO THIS. THE CUSTOMER HAD BEEN USING KINESIO TAPE FOR THE PAST FEW MONTHS, WHICH WAS REMOVED ABOUT 2-3 DAYS PRIOR TO APPLYING THE STRENGTHTAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774923 STRENGTH TAPE ORTHOPEDIC TAPE HXT SUZHOU SUNMED CO LTD 6300-SHLDR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other