BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1414630 · Received July 2, 2009

    Report

    Report Number
    2522801-2009-00019
    Event Type
    Other
    Date Received
    July 2, 2009
    Date of Event
    May 13, 2009
    Report Date
    July 2, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE OF THIS REPORT, THE SURGICAL SPECIALTIES FACILITY IN (B)(6) HAS NOT RECEIVED ANY COMPLAINT PRODUCT FOR EVALUATION. METHOD: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. FURTHERMORE, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD (DHR) WERE REVIEWED FOR THE FINISHED GOOD LOT NUMBER REPORTED. NO RELEVANT FINDINGS WERE NOTED DURING THIS REVIEW. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. ANGIOTECH REFERENCE: (B)(4). RA-1029Q, QUILL SRS, SIZE 0, PDO, 24 X 24.

    Description of Event or Problem · 1

    THE SURGEON REPORTED: A PT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2009, WHERE QUILL SRS SIZE 0 PDO WAS USED FOR DEEP CLOSURE. APPROXIMATELY TWO (2) MONTHS POST-OPERATIVELY, THE PT PRESENTED WITH A PALPABLE MASS, LOCATED FIVE (5) CENTIMETERS BELOW THE INCISION LINE. A MASS WAS SURGICALLY REMOVED AND FOUND TO CONTAIN FIVE (5) INCHES OF SUTURE MATERIAL, WHICH HAD MIGRATED FROM THE ORIGINAL SURGICAL SITE.

    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 M539450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE