BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOPOINT MEDICEL INJECTOR

    MDR report key: 1157688 · Received September 10, 2008

    Report

    Report Number
    2023826-2008-01171
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 28, 2008
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INJECTOR BARREL IS BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS PUSHING THE PLUNGER ON A MEDICEL NANOPOINT INJECTOR AND FELT RESISTANCE WITH THE PLUNGER ABOUT HALF WAY DOWN THE BARREL. THE SURGEON THOUGHT THE BARREL MIGHT BE BENT. THERE WAS NO LENS USED AND NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NANOPOINT MEDICEL INJECTOR INTRAOCULAR LENS INJECTION SYSTEM MSS MEDICEL AG MEDICEL INJECTOR 075805

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL MEDICEL NANOPOINT