BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOURNI-COT

    MDR report key: 14406871 · Received May 16, 2022

    Report

    Report Number
    14406871
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 11, 2022
    Manufacturer
    MAR-MED INC.
    Product Code
    GAX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRODUCT PACKAGING INCORRECT- PRODUCTION IDENTIFIER (PI) IN THE BARCODE, FOR BOTH BOX AND UNIT LABELS, CONTAIN INCORRECT DATA. THE EXPIRATION DATE IN THE BARCODE PI FOR THE UNITS/BOX OF TOURNI-COTS THAT YOU RECEIVED SHOW THE DATE OF MANUFACTURE, RATHER THAN THE EXPIRATION DATE. THIS ERROR CAUSES OUR PRODUCT TO APPEAR EXPIRED ON THE DAY THEY WERE MANUFACTURED WHEN YOU SCAN THE BARCODE OR REVIEW HUMAN READABLE PI TO CHECK THE EXPIRATION DATES. THE TRUE EXPIRY DATE IS THREE (3) YEARS AFTER THE DATE OF MANUFACTURE AND SHOWN CORRECTLY IN THE EXPIRATION DATE FIELD AT THE TOP OF THE LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428990 TOURNI-COT TOURNIQUET, NONPNEUMATIC GAX MAR-MED INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown