BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABDOMINAL TRANSPLANT PACK

    MDR report key: 24115887 · Received January 20, 2026

    Report

    Report Number
    1047429-2026-00001
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    June 21, 2024
    Report Date
    January 20, 2026
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    LRO
    UDI-DI
    10809160319628
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. AVID MEDICAL IS A CONVENIENCE KIT MANUFACTURER. THE COMPLAINT COMPONENT (PART NUMBER 5308259, LOT P64795) IS SUPPLIED BY (B)(4) INC. AVID MEDICAL PERFORMED A DEVICE HISTORY REVIEW OF COMPLAINT LOT FROM ASSEMBLY. ALL TRAYS INSPECTED DETECTED NO COMPONENT DEFECTS, NO ADDITIONAL HANDLING WAS PERFORMED. ALL REQUIRED INSPECTIONS WERE PERFORMED PRIOR TO PRODUCT RELEASE. THE SUPPLIER WAS CONTACTED TO INQUIRE ABOUT ANY KNOWN ISSUES AND TO OBTAIN THE CONTAINER SPECIFICATIONS; THEY REPORTED NO COMPLAINTS RELATED TO THE CONTAINER. THE CURRENT INVENTORY OF THE AFFECTED COMPONENT IN THE WAREHOUSE WAS REVIEWED, AND NO ISSUES WERE IDENTIFIED. ADDITIONAL TRAINING WAS PROVIDED TO THE EMPLOYEE INVOLVED IN THIS INCIDENT, AND REPLACEMENT ITEMS WERE ISSUED TO ADDRESS THE INCONVENIENCE. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT CONTAINER WITHIN ABDOMINAL TRANSPLANT PACK CRACKED DURING ORGAN (KIDNEY) TRANSPORT RENDERING THE ORGAN UNUSABLE. DETAILS ON THE STATUS OF DONOR OR INTENDED RECIPIENT ARE UNKNOWN, THE REPORTER INDICATED THAT THEIR POLICY IS TO NOT SHARE THESE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177368 ABDOMINAL TRANSPLANT PACK ABDOMINAL TRANSPLANT PACK LRO AVID MEDICAL, INC. NCDS019 1599604 10809160319628

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other