BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1373099 · Received April 30, 2009

    Report

    Report Number
    2522801-2009-00011
    Event Type
    Other
    Date Received
    April 30, 2009
    Date of Event
    January 1, 2009
    Report Date
    April 30, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K072028
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS ESTIMATED. THE DOCTOR IS UNCERTAIN IF THE PRODUCT USED DURING THE PROCEDURE WAS QUILL SRS MONODERM OR QUILL SRS PDO. A PART NUMBER/LOT NUMBER FOR A PDO PRODUCT WAS NOT PROVIDED. 510 (K) NUMBERS FOR QUILL SRS PDO PRODUCTS ARE AS FOLLOWS: K051609, K080680, K080985. THE DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHERMORE, THE PRODUCT LOT NUMBER IS UNKNOWN. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. (B) (4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE USING QUILL SRS AND DERMABOND FOR CLOSURE. TWO (2) MONTHS POSTOPERATIVELY, THE PATIENT PRESENTED WITH REDNESS, INFLAMMATION AND STITCH ABSCESSES. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR REMOVAL OF THE PRODUCT. THE DOCTOR IS UNCERTAIN IF QUILL SRS PDO OR QUILL SRS MONODERM WAS USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE AND NEEDLE NEW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) YA-1015Q UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE