BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE

    MDR report key: 9700890 · Received February 12, 2020

    Report

    Report Number
    1038758-2020-00007
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    December 17, 2019
    Report Date
    January 14, 2020
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 01/14/2020 CONSUMER STATED WOULD SEEK MEDICAL TREATMENT. BASED ON THE INFORMATION RECEIVED, ASO OPTED TO FILE AN MDR. AS OF 02/11/2020 UNUSED RETAINED SAMPLES OF THE SAME LOT AS THE PRODUCT REPORTED AND RETURNED PRODUCT WERE SUBMITTED TO THE LAB FOR TESTING WITH NO DEFECTS NOTED. IN ADDITION, ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS WITH NO ISSUES NOTED.

    Description of Event or Problem · 1

    ON THE INITIAL REPORT OF (B)(6) 2019 CONSUMER STATED THAT PRODUCT CAUSED RASH IN THE SHAPE OF THE BANDAGE. ON 01/14/2020 ASO RECEIVED COMPLETED CIR WHERE CONSUMER STATED WILL SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164998 EQUATE HEAVY DUTY FABRIC BANDAGES ANTIBACTERIAL KGX ASO LLC UPC#681131006736 00112037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other