BEUDAMED
    FDA Adverse Event Summary report: N

    1.5MM LACTOSORB SD TAP BODY

    MDR report key: 1840453 · Received September 21, 2010

    Report

    Report Number
    1032347-2010-00157
    Date Received
    September 21, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWX
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE THE DOCTOR WAS USING THE TAP, IT BROKE AND A PORTION REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5MM LACTOSORB SD TAP BODY TAP HWX BIOMET MICROFIXATION 274840

    Patients

    Seq Age Sex Outcome Treatment
    1