BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM MANUAL

    MDR report key: 8028878 · Received November 1, 2018

    Report

    Report Number
    1931563-2018-00002
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    September 14, 2018
    Report Date
    October 1, 2018
    Manufacturer
    POS-T-VAC MEDICAL
    Product Code
    LKY
    UDI-DI
    00857312008008
    PMA / PMN Number
    K974173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS THAT WHEN TRANSFERRING THE TENSION RING TO THE BASE OF HIS PENIS, HIS TESTICLES WERE SUCKED INTO THE TUBE RIGHT WHEN HE TRANSFERRED THE RING. AFTER THE RING WAS FULLY OFF THE TUBE AND ONTO THE PATIENT IS WHEN HE REALIZED THAT HIS TESTICLES WERE IN THE RING AS WELL. HE BELIEVES HE WAS USING THE SMALLEST RING BUT WAS NOT SURE. WHEN TRYING TO REMOVE THE RING, HE HAD TO PULL BOTH OF HIS TESTICLES OUT OF THE RING TO ALLOW FOR THE RING TO BE REMOVED FROM HIS PENIS. HE WAS SORE FOR A FEW DAYS AFTERWARDS AND THOUGHT THE PAIN WOULD SUBSIDE WITH TIME BUT HE REPORTS THAT IT ONLY GOT WORSE. HE IS HAVING TROUBLE GETTING UP FROM A SEATED POSITION OR WHEN LYING DOWN. THE PATIENT DID RETURN THE DEVICE AND ALL OF THE COMPONENTS AS REQUESTED. THE RETURNED BOX INCLUDED 1-ESTEEM MANUAL PUMPHEAD, 1- STANDARD PENILE TUBE, 1-RINGLOADER, 2-COMFORT INSERT, 1-TUBE OF LUBRICANT, 4-PRESSURE POINT TENSION RINGS SIZE A, B, C AND D, 1-BLACK STORAGE BAG, AND 1-INSTRUCTIONAL VIDEO. THE GENERAL MANAGER PREFORMED THE TESTING ON THE DEVICE AND COMPONENTS. THE PUMPHEAD WAS TESTED AND PERFORMED ACCORDING TO FDA STANDARDS. PRESSURE POINT TENSION RINGS WERE EXAMINED, TESTED AND APPEAR TO HAVE NO DEFECTS, DEFORMITIES OR TEARS. DEVICE AND PRESSURE POINT TENSION RINGS WORK AS THEY WERE DESIGNED AND FOR INTENDED USE. ALL OTHER COMPONENTS WERE INSPECTED AND THERE WERE NO DEFECTS OR DEFORMITIES. THERE WAS NO MALFUNCTION OF THE DEVICE OR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869272 ESTEEM MANUAL ESTEEM MANUAL LKY POS-T-VAC MEDICAL 1130 M-2018-0713 00857312008008

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention TENSION RINGS, TUBE, RINGLOADER, AND INSERT