BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 3150460 · Received June 6, 2013

    Report

    Report Number
    3005099803-2013-04304
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2007. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN'S NURSE, THE PATIENT HAD NO COMPLAINTS OR COMPLICATIONS REPORTED IN THE POST-OPERATION VISIT ON MAY 16, 2007. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251802 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other