BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE STERILE COTTON TIPPED APPLICATORS

    MDR report key: 3807206 · Received May 8, 2014

    Report

    Report Number
    MW5036059
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    COTTON TIPPED SWAB USED TO PROBE TUNNEL WOUND. TIP OF APPLICATOR BROKE IN THE WOUND REQUIRING SHARP DEBRIDEMENT FOR RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279644 MEDLINE STERILE COTTON TIPPED APPLICATORS MEDLINE STERILE COTTON TIPPED APPLICATORS KXG MEDLINE INDUSTRIES MDS202000 506524393

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other