BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYSORB

    MDR report key: 8662950 · Received June 3, 2019

    Report

    Report Number
    1219930-2019-03241
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    March 29, 2019
    Report Date
    June 3, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    UDI-DI
    10884521044975
    PMA / PMN Number
    K963253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING CAESAREAN SECTION PROCEDURE, THE SURGEON FOUND THE SUTURES AND THE NEEDLE DETACHED WHEN UNPACKING IT DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457818 POLYSORB SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP LLC NORTH HAVEN GL-123 A8H0393X 10884521044975

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR