BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA SMALL APPLIER

    MDR report key: 1172447 · Received September 22, 2008

    Report

    Report Number
    3005075853-2008-01840
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 09/22/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PACKAGING WAS OPENED, A TEAR WAS FOUND COMPROMISING THE STERILITY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA SMALL APPLIER GDO ETHICON ENDO-SURGERY, LLC NA D4G74L

    Patients

    Seq Age Sex Outcome Treatment
    1