BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 3/0 (2) 90CM 2XHR30 (M) .RCP

    MDR report key: 4213906 · Received October 6, 2014

    Report

    Report Number
    2916714-2014-00774
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 4, 2014
    Report Date
    October 6, 2014
    Manufacturer
    B, BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MFG SITE EVAL SAMPLES RECEIVED: 2 UNOPENED RACEPACKS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE (B)(4) UNITS IN OEM STOCK. TESTED THE NEEDLE ATTACHMENT OF THE SAMPLES RECEIVED AND THE RESULTS FULFILLED THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD BREAKS EASILY FROM NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625112 PREMILENE 3/0 (2) 90CM 2XHR30 (M) .RCP SYNTHETIC SUTURE GAW B, BRAUN SURGICAL SA C2090001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other