BEUDAMED
    FDA Adverse Event Other Summary report: N

    PMT INTEGRA TISSUE EXPANDER

    MDR report key: 1706447 · Received May 28, 2010

    Report

    Report Number
    2182979-2008-00001
    Event Type
    Other
    Date Received
    May 28, 2010
    Date of Event
    October 1, 2008
    Report Date
    May 28, 2010
    Manufacturer
    PMT CORP.
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING INITIATED FOLLOWING AN FDA FIELD AUDIT RECOMMENDING A COMPLETE REVIEW OF PAST COMPLAINTS. THIS FILING IS A RESULT OF THAT REVIEW. AN EVAL OF THE DEVICE WAS PERFORMED ON (B)(6) 2008. THE INVESTIGATION FOUND TWO (2) NEEDLE HOLES BELOW THE TISSUE EXPANDER PORT CAUSED BY A NEEDLE OR OTHER SHARP INSTRUMENT. THE PIN HOLES WERE THE CAUSE OF THE MALFUNCTION. THE PIN HOLES COULD ONLY HAVE BEEN CAUSED DURING MISHANDLING AT THE USER FACILITY, NOT IN MFG.

    Description of Event or Problem · 1

    THE HOSP CONTACTED PMT TO REPORT A DEFLATION IN THE EXPANDER. THE DEVICE HAD TO BE EXPLANTED ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PMT INTEGRA TISSUE EXPANDER TISSUE EXPANDER FWM PMT CORP. 3612ES-62-2I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention