BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 4/0 (1.5) 90CM 2XHR26 CV

    MDR report key: 3941121 · Received April 25, 2014

    Report

    Report Number
    2916714-2014-00296
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 25, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S.; HOWEVER, SIMILAR DEVICE IS. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). CUSTOMER GETS THE FEEL THAT THE NEEDLE WAS OILY/SLIPPERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250718 OPTILENE 4/0 (1.5) 90CM 2XHR26 CV CARDIAC SUTURE GAL B. BRAUN SURGICAL S.A. C3090907 113371V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other