BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICRON GREEN 1 (4) 75CM DS30 (M)

    MDR report key: 3880641 · Received May 28, 2014

    Report

    Report Number
    2916714-2014-00416
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    March 21, 2014
    Report Date
    May 28, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAT
    PMA / PMN Number
    K012201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON 05/28/2014. MFG SITE EVAL: EVAL ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). NEEDLE DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313555 PREMICRON GREEN 1 (4) 75CM DS30 (M) SYNTHETIC ABSORBABLE SUTURE GAT B. BRAUN SURGICAL S.A. C0026533 613484

    Patients

    Seq Age Sex Outcome Treatment
    1 Other