BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPCO

    MDR report key: 5368270 · Received January 14, 2016

    Report

    Report Number
    1038758-2016-00004
    Event Type
    Injury
    Date Received
    January 14, 2016
    Date of Event
    December 5, 2015
    Report Date
    December 15, 2015
    Manufacturer
    JIANGSU NANFANG MEDICAL CO. LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 1/14/2016 ASO HAS NOT OBTAINED RETURNED SAMPLES OR A LOT NUMBER FROM THE CONSUMER. HOWEVER, ASO HAS REVIEWED THE COMPLAINT DATABASE TO LOOK FOR PREVIOUS COMPLAINTS WITH THIS DEVICE AND THERE HAVE NOT BEEN ANY ADVERSE EVENTS REPORTED PRIOR TO THIS ONE. IN ADDITION, ASO HAS OBTAINED REPORTS FOR THE SHIPMENT HISTORY FOR THE DEVICE FROM OCTOBER 6, 2015 TO NOVEMBER 18, 2015. THE TESTS PERFORMED FOR ADHESION TO STEEL ARE ACCEPTABLE. ASO HAS REVIEWED RESULTS OF BIOCOMPATIBILITY TESTS AS WELL.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT SHE USED THE DEVICE FOR THE FIRST TIME ON (B)(6) 2015 AND REAPPLIED IT DAILY UNTIL (B)(6) 2015 WHEN SHE HAD A PAINFUL BLISTERING REACTION ON HER BACK. CONSUMER WAS PRESCRIBED A TOPICAL MEDICATION BY DERMATOLOGIST OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25252 TOPCO WATERPROOF TAPE 1/2IN. X 10 YDS. KGX JIANGSU NANFANG MEDICAL CO. LTD. UPC036800186002

    Patients

    Seq Age Sex Outcome Treatment
    1