BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1321323 · Received February 13, 2009

    Report

    Report Number
    2522801-2009-00004
    Event Type
    Other
    Date Received
    February 13, 2009
    Date of Event
    December 17, 2008
    Report Date
    February 13, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND QUILL SRS PRODUCT WAS ALSO REPORTED. THE PRODUCT INFO IS AS FOLLOWS: MODEL/CATALOG#: YA-1015Q, LOT#: M503450, EXP. DATE: 10/31/2010, DEVICE MANUFACTURE DATE: 10/2008, 510(K)#: K072028. ALL OTHER INFO RECORDED ON THIS FORM IS APPLICABLE TO BOTH DEVICES. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED FOR BOTH PRODUCTS REPORTED. NO PERTINENT FINDINGS WERE NOTED. (B)(4), RA-1029Q, SIZE 0, PDO, YA-1015Q, SIZE 2-0, MONODERM.

    Description of Event or Problem · 1

    THE PT UNDERWENT A TOTAL KNEE ARTHROPLASTY USING QUILL SRS, SIZE 2-0, MONODERM, FOR CLOSURE OF THE SUPERFICIAL (SUBCUTICULAR) LAYER AND QUILL SRS, SIZE 0, PDO, FOR CLOSURE OF THE INTERMEDIATE (SUBCUTANEOUS) LAYER. THREE (3) DAYS FOLLOWING THE PROCEDURE, WHILE STILL IN THE HOSPITAL, THE PT EXPERIENCED A PARTIAL DEHISCENCE OF THE SUBCUTICULAR LAYER. THE PT WAS MANAGED WITH PLACEMENT OF STAPLES IN THE AFFECTED AREA. ONE (1) WEEK POSTOPERATIVELY, THE PT EXPERIENCED AN ADDITIONAL PARTIAL SUBCUTICULAR DEHISCENCE AND A PARTIAL SUBCUTANEOUS DEHISCENCE. THE PT WAS MANAGED IN THE EMERGENCY ROOM UNDER CONSCIOUS SEDATION TO IRRIGATE AND CLOSE THE WOUND USING CONVENTIONAL SUTURE AND STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE WITH NEEDLE NEW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) RA-1029Q M456830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE.