BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 1 (4) 90CM HR37S (M)

    MDR report key: 3982759 · Received June 16, 2014

    Report

    Report Number
    2916714-2014-00461
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 16, 2014
    Manufacturer
    B BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K031286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVAL: EVAL IS ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). SUTURE FRAYS DURING CLOSING OF ABDOMINAL WALL. DEHISCENCE 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353485 SAFIL VIOLET 1 (4) 90CM HR37S (M) SUTURE GAM B BRAUN SURGICAL S.A. C1048597 113452

    Patients

    Seq Age Sex Outcome Treatment
    1