BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIPORT 5.5MM SHORT SECONDARY PORT

    MDR report key: 1250829 · Received November 25, 2008

    Report

    Report Number
    2647580-2008-00659
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Report Date
    October 31, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. PT GENDER: UNK. ACCORDING TO THE RPTR: RUBBER VALVE IS CUTTING OFF AND FALLING ABOUT 1MM IN SIZE. THE INSTRUMENT WAS NOT USED ON THE PROCEDURE. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PT. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIPORT 5.5MM SHORT SECONDARY PORT NONE GCJ PONCE - USS P8H0247

    Patients

    Seq Age Sex Outcome Treatment
    1