BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADATO SIL - OL 5000 SYRINGE

    MDR report key: 2171309 · Received July 14, 2011

    Report

    Report Number
    MW5021396
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    May 11, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS DEFECTIVE. THE NEEDLE CAME OFF THE HUB DURING INTRAOCULAR ADMINISTRATION TO THE PT. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADATO SIL - OL 5000 SYRINGE SILICONE OIL STERILE SYRINGE 5000 MPA'S FMF BAUSCH & LOMB 13110

    Patients

    Seq Age Sex Outcome Treatment
    1