BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL CATHETER KIT

    MDR report key: 12739361 · Received November 2, 2021

    Report

    Report Number
    3013886523-2021-00463
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    October 18, 2021
    Report Date
    February 16, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K102589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BACTISEAL CATHETER (823072) WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE). 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 ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO THE DEVICE CONTAINING LATEX¿ AND POTENTIAL EFFECTS OF FAILURE CAN BE ¿PATIENT REACTION TO LATEX". 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. UNIQUE DEVICE IDENTIFICATION (UDI):(B)(4).

    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

    A PHYSICIAN REPORTED A BACTISEAL CATHETER (ID823072) WAS IMPLANTED IN (B)(6) 2021 AND WAS USED WITH 823112 (SERIAL;UNK). AN INFLAMMATORY REACTION WAS REPORTED THAT CAUSED SWELLING AND REDNESS ALONG THE CATHETER. BASED ON INFORMATION PROVIDED, CATHETER FAILURE IS UNKNOWN AND NO TREATMENT WAS GIVEN FOR THE INFLAMMATORY REACTION. THE PATIENT'S CONDITION IS STABLE AND THE SWELLING HAS DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637129 CODMAN BACTISEAL CATHETER KIT BACTISEAL CATHETER KIT JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Unknown