BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 14632120 · Received June 8, 2022

    Report

    Report Number
    3013886523-2022-00249
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    August 1, 2022
    Report Date
    June 8, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CERTAS VALVE (ID 828804) WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE) AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED; HOWEVER, THE POSSIBLE ROOT CAUSE FOR THE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE. 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

    THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00248, 3013886523-2022-00250. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828804) THAT WAS IMPLANTED IN THE PATIENT VIA L-P SHUNT IN (B)(6) 2017 WITH UNKNOWN SETTING. IT WAS USED WITH HAKIM PERITONEAL CATHETER (823045) AND THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). AN OBSTRUCTION WAS SUSPECTED, HOWEVER, ONLY THE PERITONEAL CATHETER(823045) WAS REMOVED AND REPLACED ON (B)(6) 2018. DUE TO SUSPICION OF OBSTRUCTION THE VALVE AND THE HAKIM PERITONEAL CATHETER (823045) WERE REMOVED AND REPLACED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22734 CERTAS INLIN VLV ONLY W/SPHNGD CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male