BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 3/0 (2) 90CM HR26 (M)

    MDR report key: 3812582 · Received April 17, 2014

    Report

    Report Number
    2916714-2014-00265
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 17, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG SITE EVALUATION: EVALUATION ON-GOING AT MFG SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). COMPLAINT IS THAT THE WIRE IS BROKEN, AS A RESULT, THE WOUND DEHISCENCE. ADDITIONAL INFORMATION REQUESTED. UNSURE IF THESE 3 DEVICES ARE INVOLVED IN SAME INCIDENT OR MULTIPLE. DEVICE 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236134 NOVOSYN VIOLET 3/0 (2) 90CM HR26 (M) SYNTHETIC ABSORBABLE SUTURE GAM B. BRAUN SURGICAL S.A. C0068541 113473

    Patients

    Seq Age Sex Outcome Treatment
    1 Other