BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 0 VL 5X18 BTP-1 DT

    MDR report key: 1752738 · Received July 7, 2010

    Report

    Report Number
    1219930-2010-00517
    Event Type
    Injury
    Date Received
    July 7, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 6, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: C-SECTION. ACCORDING TO THE REPORTER: AFTER SUTURING THE UTERINE WALL, THEY TRIED TO DETACH THE NEEDLE FROM THE SUTURE. HOWEVER, THE NEEDLE BROKE AND ITS TIP WENT MISSING. IT WAS CONFIRMED BY X-RAY THAT NOTHING WAS LEFT IN THE CAVITY AND THE INCISION WAS CLOSED. THERE WAS NO BLEEDING, NO TISSUE DAMAGE. NOTHING FELL INTO THE PT'S CAVITY. IT IS UNK HOW MUCH OPERATIVE TIME WAS EXTENDED BY. NO OTHER PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSORB 0 VL 5X18 BTP-1 DT ABSORBABLE SUTURE PRODUCT GAM UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other