BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB SUTURE

    MDR report key: 1338132 · Received March 5, 2009

    Report

    Report Number
    1219930-2009-00134
    Event Type
    Injury
    Date Received
    March 5, 2009
    Date of Event
    August 8, 2008
    Report Date
    January 26, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 02/24/2009.

    Description of Event or Problem · 1

    PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: THE WOUND CAME OPEN, PATIENT TAKEN BACK TO SURGERY 2008, WOUND WAS CLEANED AND CLOSED WITH ANOTHER SUTURE. PATIENT IS IN GOOD STANDING AT THE TIME OF THIS REPORT. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSORB SUTURE MID-TERM ABSORBABLE GAM NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O