BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 1133387 · Received August 22, 2008

    Report

    Report Number
    9612501-2008-00048
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 6, 2008
    Manufacturer
    SANTO DOMINGO - USS
    Product Code
    GCJ
    PMA / PMN Number
    K922123
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: ADRENALECTOMY. ACCORDING TO THE REPORTER: DURING REMOVAL OF THE SPECIMEN, THE POUCH BROKE. THE SPECIMENS AND THE BROKEN PIECES FELL INTO THE CAVITY BUT WERE REMOVED FROM THE CAVITY. NO TISSUE DAMAGE WAS REPORTED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL SPECIMEN POUCH GCJ SANTO DOMINGO - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention