BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL KNOTLESS TISSUE-CLOSURE DEVICE

    MDR report key: 2111073 · Received May 20, 2011

    Report

    Report Number
    2522801-2011-00013
    Event Type
    Other
    Date Received
    May 20, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 20, 2011
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE AVAILABLE FOR EVAL. THEREFORE, NO TESTING CAN BE PERFORMED. THE ITEM AND LOT CODE INFO WAS NOT PROVIDED. THEREFORE, THE EXPIRATION DATES AND MFG DATES ARE UNK. METHOD: THE DEVICE WAS NOT AVAILABLE FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. RESULTS/CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. WITHOUT THE FINISHED GOOD ITEM/LOT NUMBER, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. IT IS UNCERTAIN IF THE QUILL KNOTLESS TISSUE-CLOSURE DEVICE ATTRIBUTED TO THIS EVENT. A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME. (B)(4). ITEM # UNK. QUILL KNOTLESS TISSUE-CLOSURE DEVICE, PDO, LOT UNK.

    Description of Event or Problem · 1

    DR (B)(6) PERFORMED AN ABDOMINOPLASTY PROCEDURE USING A QUILL 3-0 PDO KNOTLESS TISSUE-CLOSURE DEVICE. POST OPERATIVELY, THE PT RETURNED WITH A GRANULOMAS AND INFLAMMATION ALONG THE INCISION LINE. THE PT REQUIRED AN ADD'L PROCEDURE TO DEBRIDE THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL KNOTLESS TISSUE-CLOSURE DEVICE PDO BARBED SUTURE/NEEDLE NEW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention