BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1899169 · Received October 28, 2010

    Report

    Report Number
    2522801-2010-00032
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    February 2, 2010
    Report Date
    October 28, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAM
    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 ITEM/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. (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 APPROXIMATELY ONE (1) MONTH POST OPERATIVE, THE PT EXPERIENCED WOUND DEHISCENCE OF THE INTERMEDIATE LAYER AND SKIN. CULTURE AND SENSITIVITIES WERE TAKEN AND SHOWED GROWTH OF (B)(6). MEDICAL AND SURGICAL INTERVENTION WAS REQUIRED FOR TREATMENT OF THE DEHISCENCE AND INFECTION. THE SURGEON ALSO STATED THAT HE IS UNCERTAIN IF THE QUILL SRS PRODUCT ATTRIBUTED TO THIS EVENT AS THIS PT WAS ELDERLY WITH HEALTH ISSUES. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention