BEUDAMED
    FDA Adverse Event Summary report: N

    10MM INZII RETRIEVAL SYSTEM 10/BOX

    MDR report key: 2222773 · Received August 4, 2011

    Report

    Report Number
    2027111-2011-00084
    Date Received
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVAL AND NO LOT # HAS BEEN PROVIDED TO THE MFR FOR REVIEW. ENGINEERING ASSESSMENT OF THE INCIDENT WILL BE CONDUCTED AND A F/U REPORT WILL BE SENT WITHIN 30 DAYS OR UPON COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: LAP CHOLE - "DETAILS ARE UNK. PHYSICIAN REPORTED TO MATERIALS MGMT THAT THE SEAM OF THE BAG TORE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM INZII RETRIEVAL SYSTEM 10/BOX MONARCH RETRIEVAL BAG GCJ APPLIED MEDICAL CD001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1