BEUDAMED
    FDA Adverse Event Other Summary report: N

    TELEFLEX MEDICAL POLYPROPYLENE SUTURE 743 TC

    MDR report key: 2414942 · Received January 4, 2012

    Report

    Report Number
    2414942
    Event Type
    Other
    Date Received
    January 4, 2012
    Date of Event
    February 21, 2011
    Report Date
    February 23, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING VAGINAL HYSTERECTOMY, CULDOPLASTY, ANTERIOR BILATERAL SACROSPINOUS FIXATION, ANTERIOR AND POSTERIOR REPAIR AND CYSTOSCOPY. USING THE BOSTON SCIENTIFIC CAPIO DEVICE DURING SACROSPINAOUS FIXATION PORTION, SURGEON PLACED SUTURE THROUGH THE LEFT SACROSPINOUS LIGAMENT AND PULLED ON THE SUTURE. WHILE DOING SO, THE BULLET OF THE SUTURE AVULSED. DESPITE USED OF RETRACTORS AND HEADLAMP, BULLET TIP COULD NOT BE ISOLATED. SURGEON OPTED TO LEAVE IN PLACE TO AVOID FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEFLEX MEDICAL POLYPROPYLENE SUTURE 743 TC POLYPROPYLENE SUTURE 743 TAPER CUT GAW TELEFLEX MEDICAL 823-124

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other