BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS PLUS INLINE VALVE 120CM

    MDR report key: 10543644 · Received September 16, 2020

    Report

    Report Number
    3013886523-2020-00101
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    August 26, 2020
    Report Date
    August 26, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). THE CERTAS VALVE WAS NOT RETURNED FOR EVALUATION(USER FACILITY "AWAITING REGULATORY RELEASE"), AND REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE COMPLETED SINCE A VALID LOT NUMBER WAS NOT PROVIDED FOR EVALUATION. THE LOT NUMBER 18230 WAS PROVIDED BUT WAS DETERMINED NOT TO BE VALID AFTER SEARCH IN OUR DATABASE. THEREFORE, THE MANUFACTURING AND EXPIRATION DATES ARE UNKNOWN SINCE THE LOT NUMBER IS CONSIDERED UNKNOWN. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT ON (B)(6) 2020 IT WAS NOTED THAT THE CERTAS PLUS VALVE WAS STUCK AT A SETTING OF 6. MEDICAL STAFF TRIED TO USE THE ETK MAGNET TO ADJUST THE VALVE, BUT IT STILL DID NOT MOVE AND REMAINED STUCK AT 6. THE PATIENT WAS TAKEN BACK INTO SURGERY AND THE SHUNT WAS EXPLANTED AND REPLACED WITH ANOTHER SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004600 CERTAS PLUS INLINE VALVE 120CM CERTAS PLUS W/ BACTISEAL JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 18230

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR