BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP SPONGE

    MDR report key: 3760760 · Received March 27, 2014

    Report

    Report Number
    3760760
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT BREAST REDUCTION SURGERY, THE DOCTOR FOUND A SMALL PIECE OF FUZZY COTTON IN THE OPEN WOUND. IT WAS DETERMINED TO BE A PIECE OF FUZZ THAT CAME FROM A LAP SPONGE. THE BLOODY PIECE OF FUZZ WAS SAVED AND PICTURES WERE TAKEN OF IT, PLUS ADDITIONAL FUZZ AND STRINGS THAT WERE COMING OFF THE SPONGES. PLASTIC SURGEONS HAVE BEEN HAVING A PROBLEM WITH MEDLINE LAP SPONGES THAT ARE VERY LINTY AND HAVE LOOSE THREADS. THE DOCTOR FOUND LINT IN THE BREAST POCKET. MEDLINE PROVIDED OUR FACILITY WITH A NEW LOT OF LAP SPONGES TO USE AND REPLACED LAP SPONGES IN BREAST RECONSTRUCTION PACKS. PICTURES WERE TAKEN AND LINT/STRINGS WERE FOUND FROM THE NEW LOT ALSO. THERE HAS BEEN NO HARM TO PATIENT. SINCE OTHER REPORTS HAVE NOW BEEN IDENTIFIED, PRODUCT ISSUE HAS BEEN RAISED TO SYSTEM LEVEL AND IS BEING FOLLOWED CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179283 LAP SPONGE GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY MEDLINE INDUSTRIES * LD4506710529

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR NOT REALLY APPLICABLE