BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PP DP DAY CASSETTE SINGLE

    MDR report key: 2800584 · Received October 22, 2012

    Report

    Report Number
    0001825034-2012-02090
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HRX
    PMA / PMN Number
    PK093409
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02090 / 02091).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. MANUFACTURE DATE JUN 30, 2011. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02090-1 / 02091-1).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SPORTS MEDICINE PROCEDURE ON (B)(6) 2012. DURING THE PROCEDURE THE CASSETTE AND TUBING WERE NOT GETTING ENOUGH BLOOD FLOW. THE SURGEON CHANGED THE TUBING AND THERE WAS STILL VERY LITTLE FLOW. THE PATIENT WAS BLEEDING AND SURGEON COULD NOT STOP THE BLEEDING WITH THE POWER PUMP. SURGEON WAS ABLE TO STOP THE BLEEDING WITH CAUTERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PP DP DAY CASSETTE SINGLE ARTHROSCOPE HRX BIOMET SPORTS MEDICINE N/A 10L22

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R