BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SMR, VD, BP

    MDR report key: 2141549 · Received June 15, 2011

    Report

    Report Number
    1718850-2011-00057
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K102983
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT PIECES OF THE UPPER JAW WERE WORN OFF DURING THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY. SORIN GROUP (B)(4) HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR EVAL. TO DATE NO PRODUCT HAS BEEN RECEIVED. INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT PIECES OF THE UPPER JAW WERE WORN OFF DURING THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VC EVH, OD, SMR, VD, BP BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1