BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP STANDARD RAPID-PORT EZ

    MDR report key: 2002445 · Received January 28, 2011

    Report

    Report Number
    2024601-2011-00009
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    November 23, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER RAPIDPORT EZ STRAIN RELIEF. MEDWATCH SENT TO FDA ON: (B)(4) 2011. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AS FOLLOWS: "CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY." "MIGRATION OF THE BAND AND/OR TIPPING OF THE ACCESS PORT CAN OCCUR, RESULTING IN REDUCED WEIGHT LOSS, WEIGHT GAIN OR OTHER COMPLICATIONS, AND POSSIBLE REOPERATION TO REMOVE OR REPOSITION THE DEVICE."

    Description of Event or Problem · 1

    COMPANY REP REPORTED THAT THE RAPID-PORT EZ ALLEGEDLY "FLIPPED" REQUIRING REPLACEMENT SURGERY. ADDITIONAL INFO PROVIDED BY THE HEALTH PROFESSIONAL NOTED THE PT "WAS UNABLE TO RECEIVE [THEIR] FIRST ADJUSTMENT BECAUSE THE PORT FLIPPED, WHICH WAS CONFIRMED BY X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AP STANDARD RAPID-PORT EZ LTI ALLERGAN NA 1853788

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR