BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIMEN RETRIEVAL BAG

    MDR report key: 10335737 · Received July 28, 2020

    Report

    Report Number
    3002590791-2020-00079
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Report Date
    July 28, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT REPORT STATED THAT THE NUMBER OF OCCURRENCES WAS 2.0. MANUFACTURER'S REPORT IS FOR THE FIRST DEVICE (OCCURRENCE). A SEPARATE MEDWATCH REPORT WILL BE SUBMITTED FOR THE SECOND DEVICE/OCCURRENCE. THE INCIDENT REPORT WAS REPORTED BY HEALTHTRUST TO GENICON'S DISTRIBUTOR PROGRESSIVE MEDICAL, INC. ON (B)(6) 2020, AND THEN PROGRESSIVE MEDICAL, INC. REPRESENTATIVE FORWARDED IT TO GENICON, INC. ON (B)(6) 2020. PROGRESSIVE MEDICAL, INC. HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ON THE FOLLOWING DATES: (B)(6) 2020.

    Description of Event or Problem · 1

    "THE BAG TORE DURING REMOVAL. THIS IS THE SECOND INSTANCE. REPORTED TO VENDOR REPRESENTATIVE. REPORTING PURPOSES ONLY." PLEASE NOTE: THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION. AFTER MULTIPLE ATTEMPTS TO COLLECT ADDITIONAL INFORMATION, WE HAVE NO PRODUCT DETAILS, NO PATIENT STATUS, AND WE DON'T KNOW THE DATE OF OCCURRENCE OF THE ALLEGED INCIDENT. THE DISTRIBUTOR SPOKE TO THE FACILITY CONTACT WHO COULD NOT CONFIRM THAT THE DEVICE INVOLVED WAS A GENICON PRODUCT. THE REPORT WILL BE UPDATED WITH ADDITIONAL INFORMATION IF IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798596 SPECIMEN RETRIEVAL BAG GCJ GENICON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1