BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 4/0 (1.5) 45CM DS19 (M)

    MDR report key: 3810526 · Received April 16, 2014

    Report

    Report Number
    2916714-2014-00257
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 16, 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

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

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD TEARS AND LINTS DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233393 PREMILENE 4/0 (1.5) 45CM DS19 (M) PREMILENE NON-CARDIOVASCULAR SUTURE GAW B.BRAUN SURGICAL S.A. C2090220 113432

    Patients

    Seq Age Sex Outcome Treatment
    1