BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVS

    MDR report key: 5228187 · Received November 16, 2015

    Report

    Report Number
    1038758-2015-00090
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Report Date
    October 6, 2016
    Manufacturer
    ASO LLC
    Product Code
    EFQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION FROM RAW MATERIAL SUPPLIER.

    Additional Manufacturer Narrative · 1

    ASO RECEIVED TEST RESULTS FROM MANUFACTURER ON (B)(4) 2016 STATING THAT NO ISSUES HAD BEEN FOUND WITH THE PRODUCT.

    Description of Event or Problem · 1

    (B)(6) 2015 THE END USER REPORTED THAT THE DEVICE IS NOT WORKING PROPERLY AS IT IS GETTING STUCK TO HER WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756968 CVS ANTIMICROBIAL NON-STICK PADS EFQ ASO LLC UPC # 50428327968 00027504

    Patients

    Seq Age Sex Outcome Treatment
    1