BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST8 FINAL ASSY JRZ

    MDR report key: 1316584 · Received February 20, 2009

    Report

    Report Number
    1527736-2008-01358
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    February 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    KNW
    PMA / PMN Number
    K003297
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY, THE PLASTIC STERILE COVER WAS BROKEN. THERE WERE NO PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST8 FINAL ASSY JRZ KNW KNW ETHICON ENDO SURGERY, INC. NA D4JE04

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| CONTROL MODULE