BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 3240816 · Received July 17, 2013

    Report

    Report Number
    3008845715-2013-00006
    Event Type
    Other
    Date Received
    July 17, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 17, 2013
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC. ANGIOTECH
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. UNUSED PRODUCT FROM THE SAME LOT REPORTED WILL BE RETURNED FOR EVAL. METHOD: THE ACTUAL DEVICE WILL NOT BE RETURNED. UNUSED PRODUCT FROM THE SAME LOT REPORTED WILL BE RETURNED FOR EVAL. RESULTS/CONCLUSIONS: THE ACTUAL DEVICE WILL NOT BE RETURNED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT WAS RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED NOR PRODUCT MANUFACTURED WITH THE SAME SUTURE COMPONENT LOT. UNUSED PRODUCT FROM THE SAME LOT REPORTED WILL BE RETURNED FOR EVAL. A F/U REPORT WILL BE SUBMITTED ONCE THE EVAL IS COMPLETED. 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: ITEM #SXPD2B405, STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE, 2CTX #2 PDO 36 X 36, LOT MBHW360.

    Description of Event or Problem · 1

    SURGICAL SUTURE #2 PDO MATERIAL USED FOR CLOSURE OF THE RECTUS MUSCLE. AFTER THE PROCEDURE, PT HAD AN EPISODE OF SEVERE COUGHING AND THEN BEGAN TO EXPERIENCE HEAVY BLEEDING. PT WAS TAKEN BACK TO THE OPERATING ROOM FOR RE-CLOSURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331819 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. ANGIOTECH SXPD2B405 MBHW360

    Patients

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