BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERI-STRIP

    MDR report key: 6045580 · Received October 20, 2016

    Report

    Report Number
    1416980-2016-16479
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Report Date
    November 23, 2016
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K041669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS EVENT OCCURRED SOMETIME IN (B)(6) 2016. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOAM OF A PERI-STRIP WAS ALL WET AND HAD A STRANGE ODOR THIS WAS IDENTIFIED AFTER THE PRODUCT WAS RECEIVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695888 PERI-STRIP MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS NA SP16G06-1165188

    Patients

    Seq Age Sex Outcome Treatment
    1