BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1182448 · Received September 12, 2008

    Report

    Report Number
    2522801-2008-00034
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 12, 2008
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS ESTIMATED. UNUSED SAMPLES FROM LOT M347160 WERE RECEIVED ON 5-SEPTEMBER-2008. SAMPLE ANALYSIS IS CURRENTLY UNDERWAY AND A FOLLOW-UP MEDWATCH REPORT WILL BE FILED ONCE THE EVALUATION IS COMPLETE. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED FOR THE FINISHED GOOD LOT NUMBER REPORTED. NO RELEVANT FINDINGS WERE NOTED DURING THIS REVIEW. (B) (4). RA-1036Q, QUILL SRS, SIZE 2-0, PDO.

    Description of Event or Problem · 1

    TWO PATIENTS UNDERWENT AN ABDOMINOPLASTY USING 2-0 QUILL SRS PDO. BOTH PATIENTS EXPERIENCED WOUND DEHISCENCE POST SURGERY. ONE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR A SECONDARY CLOSURE. THE OTHER PATIENT DID NOT REQUIRE A SECONDARY CLOSURE; HOWEVER, A SCAR REVISION IS NECESSARY.

    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 M347160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE