BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 2/0 30 U/D C-23 211S

    MDR report key: 1893620 · Received November 3, 2010

    Report

    Report Number
    1219930-2010-00825
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 7, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HEMORRHOID. ACCORDING TO THE RPTR: THE CLIENT REPORTS THAT THE NEEDLE BROKE AND STAYED INSIDE THE TISSUE; IT COULD NOT BE RETRIEVED AND THE PT HAS BEEN INFORMED. THERE WAS NO ADDITIONAL BLOOD OR TISSUE LOSS; THE OPERATION WAS NOT EXTENDED BY MORE THAN 30 MINUTES AND WAS NOT CONVERTED TO AN OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSORB 2/0 30 U/D C-23 211S ABSORBABLE SUTURE PRODUCT GAM UNITED STATES SURGICAL A0B0447

    Patients

    Seq Age Sex Outcome Treatment
    1 Other