BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LISS INSERT-GUIDE F/DIST-FEM R RADIOLUC

    MDR report key: 3191183 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-03248
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    December 5, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE POSITIONING AND COMPRESSION DEVICE CAUSED DISCOLORING. THE CONDUCTED INVESTIGATIONS CONFIRMED THAT THE PCD SHOWS TRACES OF WEAR IN THE AREA OF THE CAVITY. THE EXAMINATION ON THE BASIS OF MATERIAL AND MANUFACTURE DOCUMENTS CONCLUDES THAT THE PART WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. THE ARTICLE WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. THERE ARE NO PRODUCTION ERRORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POSITIONING AND COMPRESSION DEVICE CAUSES DISCOLORATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290763 LISS INSERT-GUIDE F/DIST-FEM R RADIOLUC FZX SYNTHES GMBH 2067070

    Patients

    Seq Age Sex Outcome Treatment
    1