BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX

    MDR report key: 16710060 · Received April 10, 2023

    Report

    Report Number
    3010692967-2023-00015
    Event Type
    Injury
    Date Received
    April 10, 2023
    Report Date
    April 10, 2023
    Manufacturer
    SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.
    Product Code
    NEW
    PMA / PMN Number
    K080985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE A LOT NUMBER HAS NOT BEEN PROVIDED AND THEREFORE WE ARE UNABLE TO PERFORM A DEVICE HISTORY RECORD REVIEW, INCLUDING STERILITY RECORDS, TO DETERMINE IF THERE WERE ANY NON-CONFORMANCE REPORTS WITH THIS ISSUE. TO DATE SAMPLES HAVE NOT BEEN RETURNED FOR REVIEW AND/OR ANALYSIS. THE COMPLAINT REPORT INDICATED PHOTOS WERE AVAILABLE BUT TO DATE NONE HAVE BEEN RECEIVED. THE COMPLAINT REPORT ALSO INDICATED THERE OTHER PATIENTS WERE INVOLVED BUT NO DETAILS WERE PROVIDED. STRATAFIX MONOCRYL SXMP2B408 AND STRATAFIX PLUS ANTIBACTERIAL SUTURES ARE NOT MANUFACTURED BY SURGICAL SPECIALTIES CORPORATION. SINCE ALL SUTURES ARE TECHNICALLY ¿FOREIGN SUBSTANCES¿ THE HUMAN BODY HAS A TENDENCY TO REJECT THEM. THE PRECAUTIONS SECTION OF THE IFU FOR THIS DEVICE STATES, ¿INFECTIONS, ERYTHEMA, FOREIGN BODY REACTIONS, TRANSIENT INFLAMMATORY REACTIONS AND IN RARE INSTANCES WOUND DEHISCENCE ARE TYPICAL OR FORESEEABLE RISKS ASSOCIATED WITH ANY SUTURE AND HENCE ARE ALSO POTENTIAL COMPLICATIONS ASSOCIATED WITH STRATFIX SPIRAL POLYPROPYLENE DEVICE. ACCEPTABLE SURGICAL PRACTICE SHOULD BE FOLLOWED WITH RESPECT TO DRAINAGE AND CLOSURE OF INFECTED WOUNDS.¿ THE ADVERSE EFFECTS SECTION OF THE IFU STATES, ¿ADVERSE EFFECT ASSOCIATED WITH THE USE OF THIS DEVICE MAY INCLUDE, WOUND DEHISCENCE, CALCULI FORMATION IN URINARY AND BILIARY TRACTS WHEN PROLONGED CONTACT WITH SALT SOLUTIONS SUCH AS URINE AND BILE OCCURS, INFECTED WOUNDS, MINIMAL ACUTE INFLAMMATORY TISSUE REACTION, AND PAIN, EDEMA AND ERYTHEMA AT THE WOUND SITE.¿ COMPLICATIONS AND SIDE EFFECTS OF AN ABDOMINOPLASTY MAY INCLUDE: PAIN AND SWELLING AFTER SURGERY. YOUR DOCTOR WILL PRESCRIBE PAIN MEDICATIONS AS NEEDED. SORENESS MAY LAST FOR SEVERAL WEEKS. YOU MAY ALSO HAVE NUMBNESS, BRUISING AND OVERALL TIREDNESS FOR THAT SAME TIME PERIOD. AS WITH ANY SURGERY, THERE ARE RISKS. YOU MAY HAVE AN INCREASED RISK OF COMPLICATIONS IF YOU HAVE POOR CIRCULATION, DIABETES, HEART, LUNG, OR LIVER DISEASE, OR IF YOU SMOKE. COMPLICATIONS CAN INCLUDE: SCARRING. HEMATOMA (BLEEDING). INFECTION. SEROMA (ACCUMULATION OF FLUID). POOR WOUND HEALING. BLOOD CLOTS. NUMBNESS OR OTHER CHANGES IN SENSATION OTHER COMPLICATIONS INCLUDE: FAT NECROSIS (DEATH OF FATTY TISSUE LOCATED DEEP IN THE SKIN). WOUND SEPARATION. SPITTING. ASYMMETRY (UNEVENNESS OR LOPSIDEDNESS). A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT OF ABSCESSES FOLLOWING THE USE OF STRATAFIX PLUS ANTIBACTERIAL SUTURES CANNOT BE CONFIRMED WITH CERTAINTY WITHOUT RECEIVING FINISHED GOOD LOT NUMBERS TO REVIEW DEVICE HISTORY RECORDS AND STERILITY RECORDS, OR WITHOUT RECEIVING DETAILS OF THE PROCEDURES PERFORMED, PATIENT''S HEALTH STATUS AT TIME OF PROCEDURES/EVENTS, CULTURE RESULTS, POST-OPERATIVE EVENTS THAT MAY HAVE OCCURRED THAT AFFECTED THE HEALING OF THE INCISIONS, OR THE SURGEON¿S TECHNIQUE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CONSUMER THAT DURING THE TOTAL KNEE REPLACEMENT IT WAS DESCRIBED BY THE CUSTOMER THAT AFTER SWITCHING TO PLUS ANTIBACTERIAL SUTURES, THEY''VE NOTICED MULTIPLE SUTURE ABSCESSES. HIS TYPICAL CLOSURE STARTS WITH A STRATAFIX SPIRAL PDO SXPD2B405 FOR THE FASCIA, AND CLOSED SKIN WITH STRATAFIX MONOCRYL SXMP2B408. NO LOTS WERE PROVIDED, BUT IT WAS NOTED THIS HAPPENED ON MORE THAN ONE PATIENT. THE PATIENT DID EXPERIENCE AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798793 STRATAFIX 2CTX #2 PDO 36 X 36 NEW SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. SXPD2B405 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention