BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1120722 · Received August 15, 2008

    Report

    Report Number
    2522801-2008-00024
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    June 6, 2008
    Report Date
    August 15, 2008
    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
    VA, 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 #: RA-1007Q. LOT #: M203860. EXPIRATION DATE: 2009. DEVICE MFR DATE: 2007. ALL OTHER PRODUCT-RELATED INFO RECORDED ON THIS FORM IS APPLICABLE TO BOTH DEVICES. THE AMOUNT OF THE ORIGINAL SUTURE (IMPLANTED IN 2008) REMOVED DURING THE SECOND CLOSURE IS UNK. PRODUCT EVAL SUMMARY: ONE (1) SMALL PIECE OF QUILL SRS SUTURE RETURNED. THE SUTURE MEASURES APPROX THREE (3) QUARTERS OF AN INCH (.75") LONG. VISUAL EXAMINATION USING MAGNIFICATION SHOWS THAT THE BARBS ARE PUSHED BACK, MOST LIKELY DUE TO USE. BOTH ENDS OF THE SUTURE WERE ALSO EXAMINED UNDER MAGNIFICATION. THE FIRST END OF THE SUTURE APPEARS SLIGHTLY FLARED AND LOOKS LIKE IT HAS BEEN CUT OR FAILED PERPENDICULAR TO THE SUTURE. THE ITP OF THE SUTURE APPEARS FAIRLY SMOOTH. THE OTHER END OF THE SUTURE IS JAGGED AND APPEARS TO TAPER DOWN TO THE END POINT/POINT OF FAILURE. THESE CHARACTERISTICS POSSIBLY SUGGEST THAT THIS END WAS TORN. EVAL OF THE SAMPLE REVEALED DIFFERENT CHARACTERISTICS ON THE OPPOSING ENDS OF THE SUTURE. THE ONE END APPEARS AS IF IT MAY HAVE BEEN CUT OR SEVERED BY A SOMEWHAT SHARP OBJECT, WHILE THE OPPOSITE END OF THE SUTURE APPEARS TO BE TORN. THE CIRCUMSTANCES SURROUNDING THIS COMPLAINT, INCLUDING THE LIMITED EVENT AND PT INFO, MAKE IT DIFFICULT TO DRAW ANY DEFINITIVE CONCLUSIONS. DEVICE HISTORY RECORD REVIEW: RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED FOR THE TWO (2) FINISHED GOOD LOT NUMBERS REPORTED. NO RELEVANT FINDINGS WERE NOTED DURING THIS REVIEW. ANGIOTECH REFERENCE: RF108165. RA-1032Q, PDO, SIZE 1, 24X24. RA-1007Q, PDO, SIZE 2-0, 7X7.

    Description of Event or Problem · 1

    THE PT UNDERWENT AN ABDOMINOPLASTY PROCEDURE IN 2008. THE PT'S WOUND DEHISCED TWO DAYS LATER, AND HE/SHE WAS TAKEN BACK TO THE OPERATING ROOM FOR A SECOND CLOSURE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THIS EVENT-- SUCH AS PT HISTORY, SURGICAL APPROACH, POSSIBLE CAUSE OF THE DEHISCENCE, ETC.--WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE AND NEEDLE NEW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) RA-1032Q M215070

    Patients

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