BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SPIRAL PDS PLUS UNKNOWN

    MDR report key: 19949971 · Received August 9, 2024

    Report

    Report Number
    2210968-2024-08296
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 9, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 2360 G/M. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. SHOULD FURTHER DETAILS BE PROVIDED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: AM J OBSTET GYNECOL MFM. 2024 JUL 15:101431.

    Description of Event or Problem · 0

    TITLE: BARBED VERSUS CONVENTIONAL SUTURES FOR CESAREAN UTERINE SCAR DEFECTS: A RANDOMIZED CLINICAL TRIAL. THIS MULTICENTER, PARALLEL-GROUP, RANDOMIZED, CONTROLLED CLINICAL TRIAL COMPARED CLINICAL AND ULTRASONOGRAPHIC OUTCOMES OF UTERINE SCAR DEFECTS AFTER C-SECTION WITH BARBED AND CONVENTIONAL SMOOTH THREAD SUTURES. THE PARTICIPANTS WERE WOMEN REQUIRING THEIR FIRST CESAREAN DELIVERY BETWEEN MAY 2020 AND MARCH 2023. OF THE 1211 PARTICIPANTS ENROLLED, 298 UNDERWENT CESAREAN SECTION AND 253 WERE FOLLOWED-UP UNTIL JULY 2023. PARTICIPANTS WITH SINGLETON PREGNANCIES WERE RANDOMLY ASSIGNED (1:1 RATIO) TO RECEIVE EITHER CONVENTIONAL OR SPIRAL THREAD SUTURES WITH A DOUBLE-LAYER CONTINUOUS SUTURE. THE STUDY PERIOD COMPRISED THE TIME OF CONSENT TO THE 6- TO 7-MONTH EXAMINATION. INITIALLY, THE INCISION ENDS WERE SECURED USING 1-0 POLYGLACTIN (JMDN CODE: 17471000;APPROVAL NUMBER: 15700BZY01341000; VICRYL CONTROLLED RELEASE; ETHICON, JOHNSON &JOHNSON, NEW BRUNSWICK, NJ, USA) AND A SINGLE Z-STITCH APPROACH. THE ENDS WERE STABILIZED WITH CURVED FORCEPS TO ENSURE THAT THEY WOULD REMAIN IN PLACE, AND THE SUTURE WAS APPLIED PERPENDICULAR TO THE MUSCLE LAYER NEAR THE ENDS OF THE INCISION. DURING FIRST-LAYER SUTURING OF THE UTERINE INCISION, THE END WAS SECURED WITH A BARBED SUTURE (0-STRATAFIX SPIRAL PDS PLUS; JMDN CODE:16584000; APPROVAL NUMBER:22900BZX00123000; ETHICON, JOHNSON & JOHNSON), WHICH COMPRISES 0.40- TO 0.499-MM POLYDIOXANONE THREADS,31 OR A CONVENTIONAL SUTURE (0-VICRYL; JMDN CODE: 17471000;APPROVAL NUMBER: 15700BZY01341000; ETHICON, JOHNSON & JOHNSON), WHICH COMPRISES 0.35- TO 0.399-MM POLYGLACTIN THREADS. REPORTED COMPLICATIONS IN THE BARBED SUTURE GROUP INCLUDE UTERINE NICHES (N=32) AND IN THE CONVENTIONAL SUTURE GROUP INCLUDE (N=75). OTHER COMPLICATIONS INCLUDES MATERNAL SURGICAL COMPLICATIONS (N=?), OR POSTOPERATIVE COMPLICATIONS (N=?). IN CONCLUSION, DOUBLE-LAYER BARBED SUTURES DURING CESAREAN DELIVERY MAY PREVENT CESAREAN SECTION SCAR DEFECTS AND POSTOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205147 STRATAFIX SPIRAL PDS PLUS UNKNOWN SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other