BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INST OIL W/FILTER, AL-II/III

    MDR report key: 2903698 · Received January 4, 2013

    Report

    Report Number
    1045834-2013-00040
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. IF ADD'L INFO IS RECEIVED,A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE PRODUCT HAD "STRANGE BROWN PARTICLES FLOATING IN A NEW BOTTLE". THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO INJURIES REPORTED. PER REPORTER, THE PRODUCT WOULD NOT BE SENT IN. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5129 INST OIL W/FILTER, AL-II/III GEY THE ANSPACH EFFORT, INC. F413070076

    Patients

    Seq Age Sex Outcome Treatment
    1