BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1508081 · Received October 14, 2009

    Report

    Report Number
    2522801-2009-00028
    Event Type
    Other
    Date Received
    October 14, 2009
    Date of Event
    September 1, 2009
    Report Date
    October 14, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (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

    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/CONCLUSIONS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. ANGIOTECH REFERENCE: (B)(4), ITEM # UNKNOWN, QUILL SRS, 2-0 PDO, LOT# UNK.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED: (B)(6) HAD THREE (3) SEPARATE CASES OF POST-OPERATIVE INFECTION. THE FIRST CASE WAS A BREAST REDUCTION DONE ON (B)(6) 2009. QUILL 2-O PDO WAS USED BUT IT IS NOT KNOWN WHICH LAYER OF TISSUE WAS CLOSED WITH THE PRODUCT. THIS PATIENT DEVELOPED A POST-OPERATIVE INFECTION ON APPROXIMATELY DAY 14. THE PATIENT WAS TREATED WITH LEECH THERAPY. CULTURES SHOWED GROWTH OF AEROMONAS SOBRIA, HOWEVER, THE SURGEON BELIEVES THAT THIS INFECTION WAS NOT RELATED TO QUILL, BUT WAS RELATED TO THE LEECH THERAPY. SECOND CASE WAS DONE ON (B)(6) 2009. BREAST REDUCTION COMPLETED USING 2-O PDO. AGAIN, THE LAYER OF CLOSURE IS UNKNOWN. THIS PATIENT PRESENTED WITH A POST-OPERATIVE INFECTION ON APPROXIMATELY DAY 17-21. CULTURES SHOWED GROWTH OF (B)(6). THIRD CASE WAS A BRANCHIOPLASTY WITH ABDOMINOPLASTY AGAIN USING 2-O PDO WITH LAYER OF CLOSURE UNKNOWN. THIS PATIENT ALSO DEVELOPED A POST-OPERATIVE INFECTION ON APPROXIMATELY DAY 21. CULTURES SHOWED (B)(6) AS WELL. ALL OF THE REPORTED CASES WERE ADMINISTERED ANTIBIOTICS. UNABLE TO OBTAIN COMPLETE DETAILS OF THE CASES SUCH AS ADDITIONAL PRODUCTS USED FOR CLOSURE, LAYER OF TISSUE CLOSURE AND SURGICAL TECHNIQUE USED. SURGEON ALSO USES (B)(6) FOR CLOSURE, HOWEVER, MINIMAL INFORMATION HAS BEEN PROVIDED BY THE SURGICAL CENTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE