BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE

    MDR report key: 12344903 · Received August 19, 2021

    Report

    Report Number
    1038758-2021-00029
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    July 23, 2021
    Report Date
    August 19, 2021
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT BY THE CUSTOMER DID NOT INDICATE THAT AN MDR WOULD BE REQUIRED. HOWEVER, PER THE INFO RECEIVED ON 07/23/2021 MEDICAL TREATMENT WAS SOUGHT. BASED ON THE INFORMATION RECEIVED, ASO OPTED TO FILE AN MDR. AS OF 08/16/2021 ASO EVALUATED UNUSED RETURNED AND RETAINED SAMPLES OF THE SAME LOT WITH NO DEFECTS NOTED. IN ADDITION, ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS.

    Description of Event or Problem · 1

    ON THE INITIAL REPORT, RECEIVED BY ASO ON 06/21/2021 CONSUMER STATED THAT THE PRODUCT PULLED OFF THE SKIN ON HER ARM, CAUSING ALSO PAIN. THE COMPLETED CUSTOMER INFORMATION REQUEST (CIR) RECEIVED FROM THE CONSUMER ON 07/23/2021, STATED THAT THE ISSUE WAS WITH THE TAPE AND THAT SHE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242293 EQUATE ANTIBACTERIAL STRONG STRIPS ADHESIVE BANDAGES KGX ASO LLC UPC#017276236606 00134775

    Patients

    Seq Age Sex Outcome Treatment
    1 Other