BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 1 UD 5X18 BTP-X DT

    MDR report key: 1900242 · Received November 10, 2010

    Report

    Report Number
    1219930-2010-00852
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 14, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: AAA. ACCORDING TO THE REPORTER: THE INITIAL SURGERY WAS ON (B)(6) 2010 AND ON (B)(6) 2010, THE PT'S INCISION DEHISCED DUE TO PRESSURE ON HIS/HER ABDOMEN. THE DOCTOR FOUND BROKEN SUTURE AT 2 CM FROM KNOTS BUT THE KNOTS WERE TIED PROPERLY. THE PT WAS RE-OPERATED AND THERE WAS REPORTED TISSUE DAMAGE. NOTHING FELL INTO THE PT'S CAVITY. THERE WAS NO BLEEDING. THE PT'S CONDITION IS UNDER OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other