BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROLENE

    MDR report key: 3181359 · Received June 7, 2013

    Report

    Report Number
    3181359
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLUE MONOFILAMENT SUTURE SHREDDED DURING USE ON A SURGICAL PATIENT. STAFF OBTAINED MORE SUTURES. TWO DIFFERENT SUTURES WERE USED WITH THE SAME LOT NUMBER AND BOTH SHREDDED. THE SURGEON OBTAINED SUTURE FROM A DIFFERENT LOT NUMBER THAN THE ONES PREVIOUSLY USED AND WAS ABLE TO USE IT WITHOUT DIFFICULTY. NO PATIENT HARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SUTURE USED DURING SURGICAL PROCEDURE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253526 PROLENE POLYPROLENE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. * GAP242
    253527 PROLENE POLYPROLENE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. * GAP242
    253528 PROLENE POLYPROLENE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. * GAP242

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO