BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1416682 · Received May 12, 2009

    Report

    Report Number
    2522801-2009-00015
    Event Type
    Other
    Date Received
    May 12, 2009
    Date of Event
    March 1, 2009
    Report Date
    May 12, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K052373
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION TO THE REPORTED PPN MATERIAL TWO OTHER QUILL SRS PRODUCTS WERE ALSO REPORTED. THE OTHER REPORTED PRODUCT MATERIAL WAS REPORTED AS 2-0 PDO AND 3-0 MONODERM MATERIAL. INFORMATION IS AS FOLLOWS: PDO MATERIAL: MODEL/CATALOG #: UNKNOWN, LOT #: UNKNOWN, EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN, 510 (K) #: K051609. MONODERM MATERIAL: MODEL/CATALOG #: UNKNOWN, LOT #: UNKNOWN, EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN, 510 (K) #: K0722028. METHOD: THE "USED" DEVICES WERE RETURNED FOR EVALUATION AND RESULTS WILL BE FORWARDED UPON COMPLETION OF REVIEW. THE PRODUCT LOT NUMBERS FOR THE QUILL SRS PDO AND MONODERM MATERIAL ARE UNKNOWN. A DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. FURTHERMORE, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD (DHR) FOR JA-1001Q-LOT M352330 WERE REVIEWED NO RELEVANT FINDINGS WERE NOTED DURING THIS REVIEW. RESULTS: A FOLLOW-UP REPORT WILL BE FORWARDED WITH RESULTS OF EVALUATION. (B)(4), QUILL SRS, UNKNOWN, SIZE 2-0, PDO, QUILL SRS, JA-1001Q, SIZE #2, PPN, QUILL SRS, UNKNOWN, SIZE 3-0, MONODERM.

    Description of Event or Problem · 1

    THE SURGEON REPORTED: A PATIENT UNDERWENT AN ABDOMINOPLASTY AND A BILATERAL BREAST AUGMENTATION ON (B)(6) 2008 WHERE QUILL SRS #2 PPN, 2-0 PDO AND 3-0 MONODER WERE USED. THE PATIENT EXPERIENCED SPITTING AT APPROXIMATELY EIGHT (8) MONTHS POST OPERATIVE. SUTURE MATERIAL WAS REMOVED USING LOCAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE WITH NEEDLE NEW SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) JA-1001Q M352330

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention NONE MADE AVAILABLE.