BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 4168976 · Received October 7, 2014

    Report

    Report Number
    3008845715-2014-00058
    Event Type
    Other
    Date Received
    October 7, 2014
    Date of Event
    August 20, 2014
    Report Date
    October 6, 2014
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    GAM
    PMA / PMN Number
    K072028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SPITTING/INFLAMMATION/REACTION. METHOD: THE ACTUAL PRODUCT INVOLVED WILL NOT BE RETURNED. PER ELECTRONIC COMMUNICATION FROM THE CUSTOMER IT WAS STATED THAT THERE ARE THREE POSSIBLE LOTS INVOLVED, THE THREE SUSPECT LOTS PROVIDED ARE; MBNQ080, MBZK810, MBKB350. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED. FINISHED GOOD PRODUCTS WERE RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. THE PRODUCT FROM THESE FINISHED GOOD LOTS AND ALL OF THE COMPONENTS MET SURGICAL SPECIALITIES PUERTO RICO INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. NO INVENTORY AVAILABLE FOR THE SUSPECT FINISHED GOOD LOTS. INFLAMMATORY TISSUE REACTION, IS A KNOWN RISK WITH ANY SUTURE MATERIAL. THE MOST PROBABLE ROOT CAUSE FOR POST OPERATIVE INFLAMMATION/REACTION CAN NOT BE DETERMINED WITH CERTAINTY BASED ON THE INFORMATION AND WITHOUT REVIEWING THE ACTUAL DEVICE INVOLVED OR TESTING STERILE SAMPLES FROM THE SAME FINISHED GOODS LOT. (B)(4). ITEM NUMBER AND FINISHED GOOD LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY CONTACT, "WE'VE HAD 5 PATIENT'S COMPLAIN OF SUTURES SPITTING OUT AND HAVING IRRITATION AROUND THE INCISION. ALSO NOTICING THE WOUND OPENING UP. "NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. REF. PR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626229 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES GAM SURGICAL SPECIALTIES PUERTO RICO INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR NONE MADE AVAILABLE