BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL KNOTLESS TISSUE CLOSURE DEVICE

    MDR report key: 3772233 · Received March 26, 2014

    Report

    Report Number
    3008845715-2014-00012
    Event Type
    Other
    Date Received
    March 26, 2014
    Report Date
    March 25, 2014
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC. ANGIOTECH PR INC.
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES FROM THE SAME FINISHED GOOD LOT NUMBER WERE RECEIVED, EVALUATED AND MEASURED AND FOUND IN COMPLIANCE. METHOD: SAMPLES FROM THE SAME FINISHED GOOD LOT NUMBER WERE RECEIVED, EVALUATED AND MEASURED AND FOUND IN COMPLIANCE. RESULTS/CONCLUSIONS: THE ACTUAL DEVICE WAS NOT RETURNED. SAMPLES FROM THE SAME FINISHED GOOD LOT NUMBER WERE RECEIVED, EVALUATED AND MEASURED AND FOUND IN COMPLIANCE. A RECORD REVIEW OF THE REPORTED FINISHED GOOD LOT WAS PERFORMED AND THERE WERE NO NON CONFORMANCES ISSUED FOR THIS LOT NOR SUTURE COMPONENT LOT. DEHISCENCE, IS A KNOWN RISK WITH ANY SUTURE MATERIAL. THE MOST PROBABLE ROOT CAUSE FOR POST OPERATIVE DEHISCENCE CAN NOT BE DETERMINED WITH CERTAINTY BASED ON THE INFO PROVIDED. REFERENCE COMPLAINT NUMBER: 5916, ITEM NUMBER: (B)(4); LOT NUMBER: MQ24660.

    Description of Event or Problem · 1

    "ORTHOPEDIC SURGEON WHO HAD A DEHISCENCE AT THE CAPSULE AND HAD TO RETURN THE PATIENT TO THE OPERATING ROOM". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178580 QUILL KNOTLESS TISSUE CLOSURE DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. ANGIOTECH PR INC. RA-1065Q MQ24660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA