BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROCEDURE PACK

    MDR report key: 11989331 · Received June 14, 2021

    Report

    Report Number
    3002808441-2021-00002
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    February 11, 2021
    Report Date
    June 13, 2021
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, LTD
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON WAS ABLE TO SEE THE PRESENCE OF FIBERS. THE COMPLAINT STATED, "THE LINT OCCURS BECAUSE THE RYCROFT IS NOT PROTECTED", HOWEVER, THIS IS A QUESTIONABLE CONCLUSION SINCE OTHER SURGEONS ALSO USE AN IDENTICAL ADDITIONAL CANNULA, ON THE OTHER HAND WITH A DIFFERENT PACK THEREFORE DIFFERENT FIELD AND NO INCIDENT HAS OCCURRED. MOREOVER WE NOW ADD SATELLITE FIELDS AND THROW AWAY THOSE CONTAINED IN THE CONCERNED PACK (591056) AND THE PROBLEM SEEMS TO BE SOLVED.

    Description of Event or Problem · 1

    THE DOCTOR USING PACK NO. 591056 REPORTED TWO (2) INFECTIONS FOLLOWING CATARACT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893280 CUSTOM PROCEDURE PACK KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD BEAVER-VISITEC INTERNATIONAL, LTD 591056 3356724

    Patients

    Seq Age Sex Outcome Treatment
    1