BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL KNOTLESS TISSUE CLOSURE DEVICE

    MDR report key: 2324510 · Received October 31, 2011

    Report

    Report Number
    2522801-2011-00030
    Event Type
    Other
    Date Received
    October 31, 2011
    Date of Event
    October 1, 2011
    Report Date
    October 28, 2011
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM/LOTCODE INFO WAS NOT PROVIDED. THEREFORE, THE EXPIRATION DATE AND MFG DATE ARE UNK. NO SAMPLES WERE AVAILABLE FOR EVAL. THEREFORE, NO TESTING CAN BE PERFORMED. ADD'L ITEM REPORTED BY THIS CUSTOMER: MONODERM, MODEL/CATALOG #: UNK, LOT #: UNK, EXPIRATION DATE: UNK, DEVICE MANUFACTURE DATE: UNK, 510 (K) #: K072028. METHOD: THE DEVICES WERE NOT AVAILABLE FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. RESULTS/CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. W/O THE FINISHED GOOD LOT NUMBER, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE ROOT CAUSE FOR THE POST OPERATIVE INFECTIONS CAN NOT BE CONFIRMED AT THIS TIME. IF ADD'L INFO IS ACQUIRED FROM THIS FACILITY, A F/U REPORT WILL BE SUBMITTED. ANGIOTECH REFERENCE: (B)(4). ITEM # UNK, QUILL KNOTLESS TISSUE CLOSURE DEVICE, PDO, MONODERM, LOTS UNK.

    Description of Event or Problem · 1

    THE DATE OF EVENT IS ESTIMATED. A SURGEON REPORTED TO AN ANGIOTECH SALES REP THAT HE HAD FIVE (5) CASES OF INFECTION FOLLOWING KNEE PROCEDURES WHERE QUILL DEVICES WERE USED. SPECIFIC PRODUCT, LOT AND MATERIAL INFO HAS NOT BEEN PROVIDED. IT IS UNK IF THE CASES OF INFECTION ARE RELATED TO THE QUILL DEVICES. NO PT SPECIFIC INFO PROVIDED. IT IS UNK WHAT TREATMENT WAS PROVIDED TO THESE PTS. LIMITED INFO WAS OBTAINED REGARDING DETAILS OF PROCEDURES PERFORMED OR THE QUILL DEVICES THAT WERE USED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN FURTHER CLINICAL DETAILS OF THE CASES WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL KNOTLESS TISSUE CLOSURE DEVICE BARBED SUTURE/NEEDLES NEW SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention