BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTER RETENTION PLATE

    MDR report key: 3810498 · Received April 15, 2014

    Report

    Report Number
    2916714-2014-00235
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    January 17, 2014
    Report Date
    April 15, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    FRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: RECEIVED PRODUCT FOUND TO BE CONFORMING TO SPECIFICATION. FEW WEEKS AGO SEVERAL FILTER HOLDERS WITH THIS FAILURE OCCURRED IN FRANCE. TWO WERE SENT IN FOR INVESTIGATION AND WERE FOUND TO BE FULLY ACCORDING TO THE SPECIFICATIONS. THERE ARE NO OTHER COMPLAINTS LIKE THESE. IN 2010 THE SEALING LIP WAS CHANGED. RESULT: IMPROVEMENT OF THE SEALING CAPACITY. NO OTHER CHANGES HAVE BEEN CARRIED OUT REGARDING THIS PRODUCT. THERE ARE NO HINTS FOR MATERIAL OR PRODUCT DEVIATIONS. ISSUE ATTRIBUTED TO HANDLING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE FILTER HOLDER DOES NOT HOLD. INCIDENT HAS OCCURRED SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230496 FILTER RETENTION PLATE FILTER HOLDER ON STERILIZATION COUNT FRG AESCULAP AG & CO. KG JK100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other