BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE/MONOSYN SET

    MDR report key: 4992701 · Received August 7, 2015

    Report

    Report Number
    2916714-2015-00674
    Event Type
    Malfunction
    Date Received
    August 7, 2015
    Report Date
    August 4, 2015
    Manufacturer
    B.BRAUN SURGICAL S.A.
    Product Code
    GAW
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K) # K980703 / K011375. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE CUSTOMER STATED THAT THE SET DID NOT CONTAIN FOUR DIFFERENT ARTICLES AS PER PRODUCT SPECIFICATION. ALSO, THE CUSTOMER REPORTED THAT 12 SAMPLES OF ONE ARTICLE WERE FOUND INSIDE. ADDITIONAL INFORMATION PROVIDED ON JULY 22, 2015 WERE THE FOLLOWING: PREMILENE 3/0 DS 24- 12 SAMPLES INSIDE. PREMILENE 2/0 DS 30 IS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521018 PREMILENE/MONOSYN SET SUTURES GAW B.BRAUN SURGICAL S.A. B0990045 M150527002

    Patients

    Seq Age Sex Outcome Treatment
    1