BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1820009 · Received August 24, 2010

    Report

    Report Number
    2522801-2010-00023
    Event Type
    Other
    Date Received
    August 24, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL FAILED DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, STERILE PRODUCT FROM THE SAME FINISHED GOOD LOT WAS RETURNED FOR TESTING ON (B)(4) 2010. METHOD: THE ACTUAL FAILED DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, STERILE PRODUCT FROM THE SAME FINISHED GOOD LOT WAS RETURNED FOR TESTING ON (B)(4) 2010 AND FORWARDED TO ANGIOTECH'S QUALITY ASSURANCE LABORATORY. RESULTS/CONCLUSION: THE RETURNED STERILE SAMPLES WERE VISUALLY EXAMINED PRIOR TO UNDERGOING PRE AND POST HYDROLYSIS AND STRAIGHT PULL TESTING PERFORMED BY A QUALITY ASSURANCE TECHNICIAN. ALL SAMPLES MET ANGIOTECH AND USP REQUIREMENTS. FURTHERMORE, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED AND NO CORRESPONDING ISSUES WERE IDENTIFIED DURING MANUFACTURING OR FINAL RELEASE. TO DATE, NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS SPECIFIC ITEM NUMBER OR FINISHED GOOD LOT. THE ROOT CAUSE OF THE INCISIONS DEHISCING POST OPERATIVELY CAN NOT BE DETERMINED AT THIS TIME. ANGIOTECH REFERENCE: (B)(4), ITEM # RA-1036Q, QUILL SRS, 2-0 PDO, LOT M082360.

    Description of Event or Problem · 1

    (B)(6) PERFORMED MULTIPLE MASTOPEXY PROCEDURES USING QUILL SRS 2-0 PDO SUTURE MATERIAL FOR A DUAL LAYER CLOSURE OF THE DEEP DERMAL AND SUBCUTICULAR LAYERS. THE SURGEON STATES THAT HE HAS HAD FIVE (5) RECENT CASES WITHIN THE LAST SIX (6) WEEKS OF DEHISCENCE OF THE VERTICAL LIMB OF THE INCISION IN THE SUBCUTICULAR LAYER. (B)(6) HAS USED THIS CLOSURE TECHNIQUE FOR SEVERAL YEARS WITHOUT INCIDENT. ALL PATIENTS WERE EMPIRICALLY PLACED ON ORAL ANTIBIOTICS. NO CULTURE AND SENSITIVITIES WERE DONE. PATIENT ALSO REQUIRED SURGICAL INTERVENTION FOR CLOSURE OF THE SUBCUTICULAR LAYERS. PATIENTS PROGRESS WELL. THE DATE OF THIS EVENT IS ESTIMATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE AND NEEDLE NEW SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) RA-1036Q M082360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention