BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 23209354 · Received October 3, 2025

    Report

    Report Number
    1118880-2025-00140
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Report Date
    October 3, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DXC
    PMA / PMN Number
    K152525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: POTENTIAL LOT NUMBERS: 0001026706, 0000945564, 0000945614, D4: POTENTIAL EXPIRATION DATES: 09/01/2027, 08/01/2027, 08/01/2027, D4: POTENTIAL UDIS: (B)(4), D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED , E3: OCCUPATION: MANAGER, H4: POTENTIAL DEVICE MANUFACTURE DATES: 03/27/2025, 02/01/2025, 02/15/2025. THE COMPLAINT CANNOT BE CONFIRMED FOR AIR LEAKAGE ISSUES BECAUSE A SAMPLE WAS NOT RETURNED FOR ASSESSMENT. WITHOUT A SAMPLE, THE EXACT ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF MULTIPLE DEVICE HISTORY RECORDS (DHRS) SHOWED THERE WERE NO ISSUES NOTED DURING THE MANUFACTURE OF THE PRODUCT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THE RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE HAZARD BASED RISK TABLE (HBRT).

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THERE WAS NO HARM TO THE PATIENT OTHER THAN ONE SMALL HEMATOMA, AND NO PATIENT INFORMATION WAS PROVIDED. THE ACCOUNT WAS UNSURE IF IT WAS AN ISSUE WITH PLACEMENT OR IF THE BAND WAS LEAKING. THEY ASSUMED THE BAND WAS LEAKING SINCE THE PATIENT ARRIVED IN RECOVERY AND THERE SHOULD HAVE BEEN 12CC OF AIR IN THE BAND AND THERE WAS ONLY 2CC. THE BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 10SEP2025: 12 ML'S OF AIR WAS INJECTED INTO THE TR BAND WHEN IT WAS APPLIED. THE EVENT OCCURRED WHILE IN RECOVERY WHEN BALLOON WAS EVALUATED THERE WAS ONLY 2CC IN BALLOON. THE APPROXIMATE SIZE OF THE SMALL HEMATOMA WAS UNKNOWN. IT WAS UNKNOWN WHAT WAS DONE TO RESOLVE THE HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319273 TR BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION TRB24-REG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown