BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL KNOTLESS TISSUE CLOSURE DEVICE

    MDR report key: 2496659 · Received March 14, 2012

    Report

    Report Number
    2522801-2012-00001
    Event Type
    Other
    Date Received
    March 14, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 14, 2012
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K072028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS ESTIMATED. NO SAMPLES WERE AVAILABLE FOR EVAL. THEREFORE, NO TESTING WAS PERFORMED. THE LOTCODE INFO WAS NOT PROVIDED. THEREFORE, THE EXPIRATION DATES AND MFG DATES ARE UNK. METHOD: THE DEVICE WAS NOT AVAILABLE FOR EVAL. NO PRODUCT EVAL WILL BE PERFORMED. RESULTS/CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT EVAL WILL BE PERFORMED. W/O THE FINISHED GOOD LOT NUMBER, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. NECROSIS IS A KNOWN AND COMMON COMPLICATION RELATED TO THIS AND SIMILAR SURGICAL PROCEDURES. OVER TIGHTENING OF ANY SUTURE MATERIAL CAN RESULT IN THIS TYPE OF CONDITION. THE SPECULATIVE REMARKS BY THE SURGEON ARE NOT SUPPORTED BY ANY FACTS. THEREFORE, A DEFINITIVE CONCLUSION CAN NOT BE DRAWN AT THIS TIME. IF ADD'L INFO IS OBTAINED AT A LATER DATE, A F/U FORM WILL BE SUBMITTED PROMPTLY. (B)(4), ITEM # YA-1016Q, QUILL KNOTLESS TISSUE CLOSURE DEVICE, 3-0 MONODERM, LOT UNK.

    Description of Event or Problem · 1

    THE DATE OF EVENT IS ESTIMATED. DR. (B)(6) HAD A PT PRESENT WITH AREOLA NECROSIS TWO (2) WEEKS POST-OPERATIVE A MASTOPEXY PROCEDURE WHERE A 3-0 QUILL DEVICE WAS UTILIZED FOR INTRACUTANEOUS CLOSURE. THE SURGEON STATED THAT BAD CIRCULATION MAY HAVE BEEN EVOKED BY THE BARBS ON THE DEVICE. IT IS NOT CERTAIN WHAT TREATMENT WAS PROVIDED TO THIS PT. MINIMAL DETAILS OF THIS CASE HAVE BEEN OBTAINED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL KNOTLESS TISSUE CLOSURE DEVICE BARBED SUTURE/NEEDLES NEW SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) YA-1016Q UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention