BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO ADVANTAGE

    MDR report key: 8422623 · Received March 14, 2019

    Report

    Report Number
    1038758-2019-00008
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    January 22, 2019
    Report Date
    January 22, 2019
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 03/06/2019 THE INITIAL COMPLAINT DID NOT INDICATE THAT AN MDR WOULD BE REQUIRED. HOWEVER, THE CONSUMER STATED ON 02/12/2019 THAT TREATMENT WAS REQUIRED. BASED ON THE INFORMATION RECEIVED, ASO OPTED TO FILE AN MDR. ASO EVALUATED UNUSED RETURNED PRODUCT AS WELL AS RETAINED SAMPLES OF THE SAME LOT NUMBER FOR ADHESION PROPERTIES. IN ADDITION, ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS AND LATEX SCREENING.

    Description of Event or Problem · 1

    THE INITIAL REPORT ON 01/21/2019 CONSUMER INFORMED THAT PRODUCT CAUSED HER A RASH. THE COMPLETED CUSTOMER INFORMATION REQUEST (CIR) WAS RECEIVED ON 02/12/2019. CONSUMER STATED THAT SHE REQUIRED TREATMENT. CONSUMER IS A (B)(6) AND SELF-TREATED THE AREA. CONSUMER INFORMED THAT THE SYMPTOMS CORRECTED AFTER SHE STOPPED USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214557 PRO ADVANTAGE STERILE, FLEXIBLE FABRIC ADHESIVE BANDAGES KGX ASO LLC *+M220P1501203I* 00091078

    Patients

    Seq Age Sex Outcome Treatment
    1 Other