BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 1 UD 5 X 18 BTP-1 DT

    MDR report key: 3348956 · Received September 5, 2013

    Report

    Report Number
    1219930-2013-00756
    Event Type
    Injury
    Date Received
    September 5, 2013
    Date of Event
    August 9, 2013
    Report Date
    August 13, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: CESAREAN SECTION. ACCORDING TO THE REPORTER: THE DEVICE WAS USED TO CLOSE THE INCISION. AT THE 2ND STITCH, THE NEEDLE WAS BROKEN WHEN IT WAS REMOVED FROM THE FASCIA. THE SURGEON DID NOT NOTICE THAT AND THE BROKEN TIP FELL INTO THE CAVITY. THE FALLEN TIP WAS DETECTED BY X-RAY AND WAS RETRIEVED FROM THE CAVITY. NO BLEEDING. NO TISSUE DAMAGE. NO PT HARM. OPERATING ROOM TIME WAS EXTENDED BY MORE THAN 30 MINUTES. PT IS FEMALE, AGE AND WEIGHT: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443474 POLYSORB 1 UD 5 X 18 BTP-1 DT POLYSORB GAM COVIDIEN, FORMERLY US SURGICAL B3B0353X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other