BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1943781 · Received December 17, 2010

    Report

    Report Number
    2522801-2010-00037
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 17, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    GAW
    PMA / PMN Number
    K052373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS EVENT IS ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, AN EVALUATION CANNOT BE PERFORMED. METHOD - THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, AN EVALUATION CANNOT BE PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. RESULTS/CONCLUSION: RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS, STERILITY RECORD AND COMPLAINT REPORTS WERE REVIEWED FOR THE REPORTED LOT. THERE WERE NO QUALITY ISSUES NOTED DURING THE MANUFACTURING PROCESSES OR WHEN THIS PRODUCT WAS RELEASED. THERE WERE NO OTHER COMPLAINTS RECEIVED FOR THIS FINISHED GOOD LOT. MINIMAL INFORMATION WAS OBTAINED FROM THE SURGEON REGARDING THE DETAILS OF THIS CASE. THE ROOT CAUSE OF THIS EVENT CANNOT BE POSITIVELY IDENTIFIED AT THIS TIME. ANGIOTECH REFERENCE: (B)(4), ITEM # JA-1005Q, QUILL SRS, (B)(4), LOT M363750.

    Description of Event or Problem · 1

    THE DATE OF EVENT IS ESTIMATED. A SURGEON PERFORMED FIRST TIME MACS LIFT USING QUILL #1 POLYPROPYLENE IN THE MALAR AREA. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN AND THE SURGEON STATED THAT THE QUILL PRODUCT WAS NOT SUPPORTING THE MALAR AREA. THE PATIENT HAD TO BE TAKEN BACK TO THE OPERATING ROOM FOR REMOVAL OF THE PRODUCT. MINIMAL INFORMATION OBTAINED FROM THE SURGEON REGARDING THE DETAILS OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE/NEEDLE GAW SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) JA-1005Q M363750

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention