BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPRELIN INSERTION TOOL

    MDR report key: 2037600 · Received March 30, 2011

    Report

    Report Number
    MW5020002
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ENDO PHARMACEUTICALS SOLUTIONS, INC.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A SUPPRELIN IMPLANT WAS INSERTED INTO A PT'S LEFT UPPER ARM. THE SUPPRELIN IMPLANT SPLIT DURING THE INSERTION DUE TO THE INSERTION TOOL. THE PHYSICIAN REMOVED THE SUPPRELIN IMPLANT THAT SPLITTED AND PLACED IN ANOTHER SUPPRELIN IMPLANT USING ANOTHER INSERTION TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPPRELIN INSERTION TOOL INSERTION TOOL MDM ENDO PHARMACEUTICALS SOLUTIONS, INC. NA 4746993

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR