BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE SURGICAL WRAP

    MDR report key: 3131146 · Received May 22, 2013

    Report

    Report Number
    MW5030270
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDLINE INDUSTRIES INC
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) HOSPITAL'S STERILE PROCESSING DEPT FOUND INSECTS IN THE MEDLINE SURGICAL WRAP. FLYING INSECTS WERE FOUND BETWEEN THE SHEETS OF WRAP. THEY WERE FOUND IN MULTIPLE DIFFERENT SIZES OF WRAP: 24 INCH LOT# 13C1875SE, 36 INCH LOT# 13A1328S, 48 INCH WRAP LOT# 13A1744S, 54 INCH WRAP LOT# 12L7952. THIS OCCURRED ON (B)(6) INTO THE MORNING OF (B)(6) 2013. A PHOTO WAS SENT TO DR (B)(6), ENTOMOLOGIST FROM IDPH. IT WAS THOUGHT TO BE A SWARM ANT. WE HAVE SEQUESTERED THE UNUSED PACKAGES OF WRAP FROM THESE LOT#. PLEASE ADVISE AS TO NEXT STEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227415 MEDLINE SURGICAL WRAP SURGICAL WRAP LRP MEDLINE INDUSTRIES INC 13C1875SE
    227416 MEDLINE SURGICAL WRAP SURGICAL WRAP LRP MEDLINE INDUSTRIES INC 13A1328S
    227417 MEDLINE SURGICAL WRAP SURGICAL WRAP LRP MEDLINE INDUSTRIES INC 13A1744S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other