BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTODIOL

    MDR report key: 12066309 · Received June 24, 2021

    Report

    Report Number
    MW5102126
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    June 10, 2021
    Report Date
    June 23, 2021
    Manufacturer
    ESSENTIAL PHARMACEUTICALS/ BRETSCH / DR. FRANZ KOHLER CHEMIE GMBH
    Product Code
    KDL
    UDI-DI
    04033133010000
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED AN UNEXPECTED OUTCOMES STATUS POST KIDNEY TRANSPLANT. WHEN REVIEWING 3 CASES ALL OCCURRING DURING THE SAME WEEK ONE OF THE COMMONALITIES WAS THE PRESERVATIVE SOLUTION. WE ARE UNSURE IF THERE IS ANY CORRELATION. BASED ON PHYSICIAN ASSESSMENT THE PATIENT EXPERIENCED TMA STATUS POST TRANSPLANT OF UNKNOWN ORIGIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957501 CUSTODIOL SET, PERFUSION, KIDNEY, DISPOSABLE KDL ESSENTIAL PHARMACEUTICALS/ BRETSCH / DR. FRANZ KOHLER CHEMIE GMBH 2021873 04033133010000

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization