BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1899170 · Received October 28, 2010

    Report

    Report Number
    2522801-2010-00034
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    August 16, 2010
    Report Date
    October 28, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K072028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE AVAILABLE FOR EVAL. THEREFORE, NO TESTING CAN BE PERFORMED. THE ITEM/LOT CODE INFO WAS NOT PROVIDED. THEREFORE, THE EXPIRATION DATE AND MFG DATE ARE UNK. ADDITIONAL ITEM REPORTED BY THIS CUSTOMER: 2-0 PDO; MODEL/CATALOG #: UNK; LOT #: UNK; EXP DATE: UNK; DEVICE MFR DATE: UNK; 510 (K) #: K051609. METHOD: THE DEVICES WERE NOT AVAILABLE FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. RESULTS/CONCLUSION: THE DEVICES WERE NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. WITHOUT THE FINISHED GOOD LOT NUMBERS, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. IT IS UNCERTAIN IF THE QUILL SRS MATERIAL ATTRIBUTED TO THIS EVENT. A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME. ANGIOTECH REFERENCE: (B)(4), QUILL SRS MONODERM / QUILL SRS PDO ITEM UNK, SIZE 2-0, LOT UNK.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED. DR (B)(6) PERFORMED A LUMBAR LAMINECTOMY USING QUILL SRS 2-0 PDO FOR INTERMEDIATE CLOSURE AND 2-0 MONODERM FOR CLOSURE OF THE SKIN. THE SURGEON STATED THAT THIRTEEN (13) DAYS POST OPERATIVE, THE PT EXPERIENCED WOUND DEHISCENCE OF THE INTERMEDIATE AND SUPERFICIAL LAYER. CULTURE AND SENSITIVITIES WERE TAKEN AND SHOWED GROWTH OF (B)(6). I & D PROCEDURE WAS NEEDED AND ANTIBIOTICS WERE ADMINISTERED FOR TREATMENT OF THE INFECTION. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention