BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL KNOTLESS TISSUE-CLOSURE DEVICE

    MDR report key: 2020226 · Received March 9, 2011

    Report

    Report Number
    2522801-2011-00004
    Event Type
    Other
    Date Received
    March 9, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 10, 2011
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    GAM
    PMA / PMN Number
    K072028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE AVAILABLE FOR EVALUATION. METHOD: THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. THEREFORE, NO TESTING CAN BE PERFORMED. RESULTS/CONCLUSION: THE DEVICES WERE NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. FURTHERMORE, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED AND THERE WERE NO CORRESPONDING ISSUES IDENTIFIED DURING MANUFACTURING OR FINAL RELEASE. TO DATE, NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THE REPORTED FINISHED GOOD LOT. IT IS UNCERTAIN IF THE QUILL KNOTLESS TISSUE-CLOSURE DEVICE ATTRIBUTED TO THESE EVENTS. DUE TO MINIMAL INFORMATION OBTAINED FROM THIS SURGEON, A DEFINITIVE CONCLUSION CAN NOT BE DRAWN AT THIS TIME. (B)(4). ITEM # YA-1023Q, QUILL, 3-0 UNDYED MONODERM, LOT M428870.

    Description of Event or Problem · 1

    DATE OF EVENT IS ESTIMATED. THREE (3) TOTAL KNEE ARTHROPLASTY PROCEDURES WERE PERFORMED USING A QUILL 3-0 MONODERM DEVICE FOR SKIN CLOSURE. THE SURGEON STATED THAT THE PATIENTS DEVELOPED ISCHEMIA IN THE SUPERFICIAL LAYER OF THE TISSUE APPROXIMATELY TWELVE (12) DAYS POST PROCEDURE. ALL PATIENTS REQUIRED ORAL ANTIBIOTICS AS WELL AS PROLONGED HEALING TIMES AND DAILY WOUND CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL KNOTLESS TISSUE-CLOSURE DEVICE QUILL 3-0 MONODERM DEVICE GAM SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) YA-1023Q M428870

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention