BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIN-COM 125 A/P

    MDR report key: 220103 · Received April 19, 1999

    Report

    Report Number
    1022819-1999-00001
    Event Type
    Injury
    Date Received
    April 19, 1999
    Date of Event
    March 22, 1999
    Report Date
    April 17, 1999
    Manufacturer
    CHATTANOOGA GROUP, INC.
    Product Code
    IKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING ROUTINE EXERCISE (3RD VISIT) FOR REHABILITATION. DURING 2ND SET OF 10 REPETITIONS, "PTA" HEARD A POP AND DISCONTINUED TREATMENT. X-RAYS REVEALED FRACTURED PATELLA. PT HAD EXTREMELY STRONG QUAD MUSCLES 4 PLUS TO 5. "PTA" STATED THERE WAS NOTHING WRONG WITH DEVICE, AS IT IS STILL IN USE TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIN-COM 125 A/P ISOKINETEC TESTING AND EVALUATION SYSTEM IKK CHATTANOOGA GROUP, INC. 125 A/P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention