BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS SEAL CAP ASSEMBLY

    MDR report key: 1831772 · Received November 30, 2007

    Report

    Report Number
    1527736-2007-08114
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    November 7, 2007
    Report Date
    November 7, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE SEAL CAP THE MEMBRANE RIPPED. NO PIECE FELL INTO THE PT. USED ANOTHER ONE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS SEAL CAP ASSEMBLY GCJ ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1