BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 3/0 (2) 75CM DS24 (M) POW

    MDR report key: 3970137 · Received April 29, 2014

    Report

    Report Number
    2916714-2014-00312
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 8, 2014
    Report Date
    April 29, 2014
    Manufacturer
    B BRAUN SURGICAL S.A.
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVAL: EVAL ON-GOING AT MANUFACTURING SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DURING PROCEDURE, SUTURE FRAYS AND IT IS NECESSARY TO USE OTHER SUTURES TO COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255548 PREMILENE 3/0 (2) 75CM DS24 (M) POW NON-CARDIOVASCULAR SUTURE GAW B BRAUN SURGICAL S.A. C0095730 513372

    Patients

    Seq Age Sex Outcome Treatment
    1