BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO TR BAND

    MDR report key: 17380178 · Received July 21, 2023

    Report

    Report Number
    MW5119898
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    July 10, 2023
    Report Date
    July 19, 2023
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ISSUE WITH A TERUMO TR BAND. TRIED 3 DIFFERENT PRODUCTS, AS IT WASN'T INFLATING. TERUMO TR BAND REF # TRB24-REG. LOT#0000326994 EXP 9.1.2025 RADIAL BANDS FAILED TO REMAIN INFLATED X 3. PT DEVELOPED A SMALL HEMATOMA DUE TO PRODUCT FAILURE. ONLY OCCURRING WITH THE REG "SIZE". REFERENCE REPORTS: #MW5119897, #MW5119899.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554661 TERUMO TR BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORP. TRB24-REG

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention