BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC IBC

    MDR report key: 1829518 · Received August 26, 2010

    Report

    Report Number
    3002037047-2010-00133
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 27, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. (B)(4) .

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNKNOWN' (NOT INFORMATION). PRODUCT PROBLEM(S): "CANNULA NOT SECURELY ATTACHING, WOBBLING DURING USE" (NO CODE AVAILABLE [SYRINGE]). A NUN REPORTED THAT THE CANNULA FROM A VISCOELASTIC SYRINGE WAS NOT SECURELY ATTACHING AND WOBBLING DURING USE. PATIENT IMPACT REMAINS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1