BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED INSTRUMENT

    MDR report key: 2972463 · Received February 15, 2013

    Report

    Report Number
    2028159-2013-00245
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ALCON- IRVINE TECHNOLOGY CENTER
    Product Code
    GAA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED EVENT OF MISLABELED CARTON WAS CONFIRMED THROUGH ATTACHED PHOTOGRAPHS. THE PRODUCT INSIDE THE CARTON WAS A 23 GAUGE PROBE. THE INDIVIDUAL PRODUCT INSIDE THE CARTON WAS LABELED CORRECTLY, BUT THE ENGLISH LABEL ON THE OUTSIDE OF THE CARTON WAS FOR A 2500 STAND ALONE PROBE. THE NATIVE LANGUAGE ((B)(6)) LABEL ON THE OUTSIDE OF THE CARTON WAS CORRECT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS STANDALONE PROBE. IN ADDITION, A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS 23 GAUGE PROBE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT THE CARTON CONTAINING 23 GAUGE PROBES WAS LABELED INCORRECTLY. THE INDIVIDUAL PRODUCTS INSIDE THE CARTON WERE LABELED CORRECTLY, BUT THE LABEL ON THE OUTSIDE OF THE CARTON WAS INCORRECT. THERE WAS NO PT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69525 UNSPECIFIED INSTRUMENT UNSPECIFIED INSTRUMENT GAA ALCON- IRVINE TECHNOLOGY CENTER NA 12015606X

    Patients

    Seq Age Sex Outcome Treatment
    1