BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS

    MDR report key: 6150978 · Received December 7, 2016

    Report

    Report Number
    1416980-2016-18111
    Event Type
    Injury
    Date Received
    December 7, 2016
    Report Date
    January 5, 2017
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL ONSET DATE WAS REPORTED AS AN UNKNOWN MONTH AND DATE IN 2016. THE INITIAL REPORTER¿S POSTAL CODE WAS REPORTED AS: NG5 1PB AND PHONE EXTENSION REPORTED AS X55039. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED AN INFLAMMATORY REACTION RELATED TO A VERITAS DEVICE. THE EVENT WAS FURTHER DESCRIBED AS INCOMPLETE INTEGRATION WITH AN UNUSUAL YELLOWY COLLECTION OF FLUID; WITH AN IMPLANT DISPLACEMENT FOLLOWING BREAST SURGERY. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT DETAILS WERE NOT REPORTED. THE PATIENT OUTCOME AND RECOVERY STATUS OF THE PATIENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803758 VERITAS MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other