BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1503783 · Received October 7, 2009

    Report

    Report Number
    2522801-2009-00026
    Event Type
    Other
    Date Received
    October 7, 2009
    Date of Event
    September 1, 2009
    Report Date
    October 8, 2009
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE PRODUCT USED BY THIS PHYSICIAN WAS NOT DISCLOSED. ONE OTHER ITEM WAS REPORTED BUT WAS NOT MENTIONED BY THE SURGEON AS ONE OF THE PRODUCTS THAT WAS USED FOR THIS SPECIFIC PROCEDURE. THERE WERE NO SAMPLES RETURNED FOR EVALUATION. METHOD: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBERS WERE REPORTED AS UNKNOWN. FURTHERMORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED WITHOUT THE LOT CODE INFORMATION. RESULTS/CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. ANGIOTECH REFERENCE: (B)(4), RA-1065Q, QUILL SRS, #2 PDO, LOT# UNKNOWN. RA-1067Q, QUILL SRS, #0 PDO, LOT# UNKNOWN.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED: (B)(5) PERFORMED A TOTAL KNEE ARTHROPLASTY USING A #2 QUILL FOR CAPSULAR CLOSURE, 2-O VICRYL FOR INTERMEDIATE LAYER CLOSURE AND STAPLES FOR SKIN CLOSURE. THE PATIENT EXPERIENCED POST-OPERATIVE HEMATOMA AND WAS TAKEN BACK TO THE OPERATING ROOM FOR AN INCISION AND DRAINAGE PROCEDURE. ALTHOUGH THERE WERE NO SIGNS OF DEHISCENCE, IT WAS NOTED THAT THE PRODUCT USED TO CLOSE THE CAPSULE WAS BROKEN IN SEVERAL AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE WITH NEEDLE NEW SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) RA-1065Q UNK

    Patients

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