BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KROGER STERILE PADS 3 X 3 12-PLY 10CT

    MDR report key: 5108683 · Received September 28, 2015

    Report

    Report Number
    1038758-2015-00079
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    YANGZHOU SUPER UNION MEDICAL MATERIAL CO., LTD.
    Product Code
    FRL
    UDI-DI
    00011110351234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ASO REACHED OUT TO CONSUMER/END USER ON 1 OCCASION TO REQUEST SAMPLES OF THE REMAINING DEVICE/PRODUCT BY RETURN MAIL FOR INVESTIGATION AND TESTING; TO DATE THERE HAS BEEN NO RESPONSE. AFTER CONDUCTING AN INVESTIGATION OF THE ADVERSE EVENT; IT WAS DETERMINED THAT THE CONSUMER/END USER MISUSED THE PRODUCT. PRODUCT SPECIFICATIONS AND LABELING DIRECTIONS FOR THIS STERILE PAD DEVICE/PRODUCT INDICATED USE FOR CLEANING WOUNDS. DEVICE EVALUATED BY MANUFACTURER - EVALUATION OF A REPRESENTATIVE SAMPLE OF THE RELATED MEDICAL DEVICE IS SUMMARIZED.

    Description of Event or Problem · 1

    CUSTOMER/END USER USED A NON-STICK PAD TO COVER A WOUND; THE PAD STUCK TO THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638827 KROGER STERILE PADS 3 X 3 12-PLY 10CT NON-STICK PADS FRL YANGZHOU SUPER UNION MEDICAL MATERIAL CO., LTD. 011110351234 2384-20150419 00011110351234

    Patients

    Seq Age Sex Outcome Treatment
    1