BEUDAMED
    FDA Adverse Event Other Summary report: N

    WASH SET 175E

    MDR report key: 2012337 · Received March 3, 2011

    Report

    Report Number
    1718850-2011-00013
    Event Type
    Other
    Date Received
    March 3, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 2, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    PMA / PMN Number
    K020647
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED IN (B)(6). SORIN GROUP (B)(4) MANUFACTURES THE WASH SET. THE ELECTA BOWL IS A COMPONENT OF THIS SET. SORIN GROUP USA IS FILING THIS MEDWATCH REPORT ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING THE PROCEDURE, IT WAS IMPOSSIBLE TO EMPTY THE ELECTA BOWL. TO DATE, SORIN GROUP (B)(4) HAS NOT RECEIVED THE PRODUCT FOR EVAL. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THERE WAS NO REPORT OF PT INJURY. THE FACILITY REPORTED THE INCIDENT TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING THE PROCEDURE, IT WAS IMPOSSIBLE TO EMPTY THE ELECTA BOWL. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WASH SET 175E AUTOTRANSFUSION DEVICE CAC SORIN GROUP ITALIA NA 1009160115

    Patients

    Seq Age Sex Outcome Treatment
    1