BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRODUCT-MED

    MDR report key: 18164708 · Received November 17, 2023

    Report

    Report Number
    1423537-2023-01001
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    January 1, 1980
    Report Date
    November 17, 2023
    Manufacturer
    PR006 PUERTO RICO-ANASCO
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT NUMBER WAS NOT PROVIDED, AND NO SAMPLE OR LOT NUMBER WAS AVAILABLE FOR INVESTIGATION, THEREFORE WE ARE UNABLE TO DETERMINE THE ROOT CAUSE. IF FURTHER INFORMATION IS PROVIDED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED. WE WILL CONTINUE TO MONITOR TRENDS AND UTILIZE THE INFORMATION AS PART OF CONTINUOUS.

    Description of Event or Problem · 0

    PLAINTIFF ALLEGES THAT HE UNDERWENT SURGERIES IN 2017 AT (B)(6), TO HAVE THE JP DRAIN INSTALLED AND THEN LATER REMOVED. DURING THE REMOVAL SURGERY, THE DRAIN BROKE, REQUIRING ADDITIONAL SURGERY TO REMOVE IT. PLAINTIFF ALLEGES HE SUFFERED UNSPECIFIED ¿SEVERE, PERMANENT AND PAINFUL INJURIES¿ AS A RESULT OF THE DRAIN BREAKAGE. IN 2019, PLAINTIFF SUED THE DOCTOR WHO IMPLANTED AND REMOVED THE DRAIN FOR MEDICAL MALPRACTICE. PLAINTIFF NOW ALLEGES THAT ¿THE DOCTORS BLAMED THE MANUFACTURER,¿ AND HAS FILED AN AMENDED COMPLAINT NAMING CARDINAL HEALTH, INC. AND CARDINAL HEALTH 200, LLC AS PRODUCT LIABILITY DEFENDANTS. THE AMENDED COMPLAINT ASSERTS CLAIMS FOR NEGLIGENCE, STRICT PRODUCT LIABILITY, AND BREACH OF WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916579 UNKNOWN PRODUCT-MED CATHETER, IRRIGATION GBX PR006 PUERTO RICO-ANASCO UNKNOWN PRODUCT-MED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization