BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1508080 · Received October 14, 2009

    Report

    Report Number
    2522801-2009-00029
    Event Type
    Other
    Date Received
    October 14, 2009
    Date of Event
    September 1, 2009
    Report Date
    October 14, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM/LOT NUMBER FOR THE 2-0 PDO PRODUCT USED BY THIS PHYSICIAN WAS NOT DISCLOSED. THERE WERE NO SAMPLES RETURNED FOR EVALUATION. METHOD: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS REPORTED AS UNKNOWN. FURTHERMORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED WITHOUT THE LOT CODE INFORMATION. RESULTS/CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED: (B)(6) HAD TWO (2) PATIENTS THAT DEVELOPED POST-OPERATIVE INFECTIONS. THE FIRST PATIENT UNDERWENT AN OPEN REDUCTION, INTERNAL FIXATION OF THE LEFT ANKLE (CLOSED FRACTURE). THE PROCEDURE WAS PERFORMED ON (B)(6) 2009 USING QUILL 2-O PDO FOR CLOSURE. THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION APPROXIMATELY TWO (2) WEEKS AFTER SURGERY. CULTURES SHOWED GROWTH OF (B)(6). THE OTHER PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY WHICH WAS PERFORMED ON (B)(6) 2009 USING QUILL 2-O PDO FOR INTERMEDIATE LAYER OF CLOSURE, STAPLES FOR SKIN CLOSURE AND AN UNKNOWN PRODUCT WAS USED TO CLOSE THE CAPSULE. THIS PATIENT DEVELOPED A POST-OPERATIVE INFECTION ON APPROXIMATELY DAY 14-17. CULTURE SHOWED GROWTH OF (B)(6). BOTH PATIENTS WERE TREATED WITH ANTIBIOTICS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE