BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAP, BOUFFANT, PROSERIES, LT WT, BLUE, 24"

    MDR report key: 2905986 · Received November 27, 2012

    Report

    Report Number
    2905986
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC
    Product Code
    FYF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    AT END OF DAY, SURGEON REMOVED BOUFFANT CAP TO FIND DEAD LIZARD INSIDE CAP. PICTURE FROM SMARTPHONE IS AVAILABLE.======================MANUFACTURER RESPONSE FOR BOUFFANT CAP, CAP, BOUFFANT, PROSERIES, LT WT, BLUE, 24" (PER SITE REPORTER).======================THE BOX WITH THE REMAINING CAPS WAS RETURNED TO THE MANUFACTURER BY DIRECTOR MATERIALS MANAGEMENT. COMPLAINT REGISTERED WITH MEDLINE CUSTOMER SERVICES REPRESENTATIVE. I HAVE ACTUAL CAP WITH DEAD LIZARD FOR RETURN TO MANUFACTURER AS WELL AS PICTURE. AWAITING RETURN LABELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAP, BOUFFANT, PROSERIES, LT WT, BLUE, 24" CAP, SURGICAL FYF MEDLINE INDUSTRIES, INC * 904515696

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR