BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION DSP 23G, ILM FORCEPS

    MDR report key: 2062228 · Received March 17, 2011

    Report

    Report Number
    3003398873-2011-00003
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THE FORCEPS WERE NOTED AS "DEFECTIVE" DURING SURGERY. PT IMPACT IS UNK AT THIS TIME. ADD'L INFO HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION DSP 23G, ILM FORCEPS FORCEPS, OPHTHALMIC HNR ALCON GRIESHABER AG 706.44 F79559

    Patients

    Seq Age Sex Outcome Treatment
    1