BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE MESH 10 X 15 CM

    MDR report key: 4727952 · Received April 17, 2015

    Report

    Report Number
    2916714-2015-00346
    Event Type
    Malfunction
    Date Received
    April 17, 2015
    Date of Event
    October 2, 2010
    Report Date
    April 17, 2015
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    FTL
    PMA / PMN Number
    K061704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVAL: EVAL IS ONGOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). COMPLAINT STATES: THE CLIENT UNDERWENT A RECTOPEXY AND HERNIA REPAIR. THE MESH USED WAS OPTILENE MESH LOT NO 110105, DIMENSIONS 10/15 CM. (B)(4). POTENTIAL CLAIM FOR PERSONAL INJURIES AS A RESULT OF AN OPERATION WHICH TOOK PLACE ON (B)(6) 2010 AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256376 OPTILENE MESH 10 X 15 CM SYNTHETIC ABSORBABLE SUTURE FTL B. BRAUN SURGICAL SA 1065040 110105

    Patients

    Seq Age Sex Outcome Treatment
    1