BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERECAID ESTEEM VACUUM ERECTION SYSTEM

    MDR report key: 785399 · Received November 17, 2006

    Report

    Report Number
    2134022-2006-00001
    Event Type
    Injury
    Date Received
    November 17, 2006
    Date of Event
    October 7, 2006
    Report Date
    November 2, 2006
    Manufacturer
    TIMM MEDICAL TECHNOLOGIES, INC.
    Product Code
    LKY
    PMA / PMN Number
    k912736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON FRIDAY OCTOBER 27, 2006, A CUSTOMER CALLED CLAIMING TO HAVE BEEN INJURED WHILE USING THE ERECAID ESTEEM AUTOMATIC VACUUM ERECTION SYSTEM. THE CUSTOMER STATED THAT, WHILE USING THE DEVICE TO CREATE AN ERECTION BY PLACING THE CYLINDER AROUND HIS PENIS, HOLDING IT TIGHTLY AGAINST THE PUBIC AREA TO CREATE A SEAL AS DESIGNED, THE VACUUM CREATED BY THE PUMP TO DRAW BLOOD INTO THE PENIS TO PRODUCE AN ERECTION DREW HIS SCROTAL TISSUE INTO THE SYSTEM CYLINDER. WHILE TRANSFERRING THE TENSION RINGS FROM THE CYLINDER TO THE PENIS, THE TENSION RINGS WERE APPLIED OVER THE SCROTAL SACK, AS WELL AS THE PENIS. THIS CAUSED THE CUSTOMER CONSIDERABLE PAIN AND DISCOMFORT AND LED THE CUSTOMER TO SEEK MEDICAL TREATMENT. THE CUSTOMER STATED THAT THE TREATING PHYSICIAN HAD TO MAKE AN INCISION INTO HIS SCROTUM TO REPAIR A "SPLIT TESTICLE". ACCORDING TO THE CUSTOMER, THE PHYSICIAN STATED THAT THE INJURY WAS CAUSED BY EITHER THE VACUUM OR THE TENSION RINGS OF THE SYSTEM. PRIOR TO THIS INCIDENT, THE CUSTOMER HAD BEEN USING THE SYSTEM 3 TO 4 TIMES A WEEK FOR APPROXIMATELY 1 1/2 YEARS. THE CUSTOMER STATED THAT HIS PHYSICIAN HAS GIVEN HIM THE OK TO CONTINUE USE OF THE DEVICE. THE ORIGINAL DEVICE WAS RETURNED BY THE CUSTOMER FOR REVIEW AND PER THE CUSTOMER'S REQUEST, WAS REPLACED WITH A NEW DEVICE. A REVIEW OF COMPLAINT HISTORY WAS CONDUCTED AND NO SAME OR SIMILAR INCIDENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERECAID ESTEEM VACUUM ERECTION SYSTEM LKY LKY TIMM MEDICAL TECHNOLOGIES, INC. 1135 0000611

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R