BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 11854388 · Received May 20, 2021

    Report

    Report Number
    3013886523-2021-00227
    Event Type
    Injury
    Date Received
    May 20, 2021
    Report Date
    June 11, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K944222
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE) AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. 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

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2021-00226. A PHYSICIAN REPORTED THAT IN 2001, A CODMAN HAKIM PROGRAMMABLE VALVE WAS IMPLANTED TO A (B)(6) YEAR-OLD FEMALE PATIENT VIA V-P SHUNT WITH A SETTING OF 100 MMH20. ON (B)(6) 2021, THE PATIENT COMPLAINED OF A HEADACHE. CONFIRMATION VIA MRI SHOWED THAT THE CATHETER HAD FALLEN OFF AND A SLIT-LIKE VENTRICLE WAS NOTED. ONLY THE VALVE WAS REPLACED ON (B)(6) 2021. THE IMPLANTED ABDOMINAL CATHETER WAS EXTENDED BY USING A CONNECTOR (823053) AND BACTISEAL (823073). THE CAUSE OF THE DEVIATION OF THE ABDOMINAL CATHETER WAS THE INCREASE IN HEIGHT OF THE PATIENT AND THE OCCURRENCE OF GRAVITATIONAL FORCE. THE PATIENT¿S CONDITION HAD IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755979 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR