BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC IBC

    MDR report key: 1834413 · Received September 10, 2010

    Report

    Report Number
    3002037047-2010-00136
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVAL. THE RPTR DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG PROCESS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INVOLVEMENT" (NO PT INVOLVEMENT). PRODUCT PROBLEM(S): "HARDER TO INJECT" (PHYSICAL RESISTANCE). A USER FACILITY REPORTED HAVING PROBLEMS WITH THE CONSISTENCY OF THE PRODUCT. IT IS HARDER TO INJECT THE SECOND TIME THEY NEED THE PRODUCT. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISC IBC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1