BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3003681312-2008-00084

    MDR report key: 1132428 · Received August 14, 2008

    Report

    Report Number
    3003681312-2008-00084
    Event Type
    Injury
    Date Received
    August 14, 2008
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WAS RETURNED; THEREFORE, AN EVAL COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MGB * *

    Patients

    Seq Age Sex Outcome Treatment
    1