BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL PENDULOUS SEAL

    MDR report key: 1379651 · Received March 9, 2009

    Report

    Report Number
    2027111-2009-00017
    Event Type
    Other
    Date Received
    March 9, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 9, 2009
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. UPON RECEIVING AND EVALUATING THE INCIDENT DEVICE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "UROLOGIST WAS USING THIS UNIT WHEN THE RUBBER END FELL IN PATIENT, SEAL COULD BE, HOWEVER, RETRIEVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL PENDULOUS SEAL PENDULOUS SEAL HET APPLIED MEDICAL RESOURCES C0600 1070549

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention