BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFX SPI PDS+ UNI VIO 18IN 0 S/A CT-1

    MDR report key: 18648017 · Received February 6, 2024

    Report

    Report Number
    2210968-2024-00975
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 1, 2024
    Report Date
    March 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031236103
    PMA / PMN Number
    K150670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT IS THE ALLEGED DEFICIENCY OF THE SUTURE? WHAT WAS THE SOURCE AND TRIGGERING EVENT OF BLEEDING? WHAT WAS THE VOLUME OF BLOOD LOSS? PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WHAT IS THE SURGEON¿S EXPERIENCE WITH THE STRATAFIX SPIRAL SUTURE? WAS THE FIXATION LOOP SECURED TO TISSUE AT THE INITIATION OF SUTURE USE DURING THE INDEX PROCEDURE? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? LOT NUMBER? RELATED MEDWATCH REPORTS: 2210968-2024-00976, 2210968-2024-00977.

    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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT IS THE ALLEGED DEFICIENCY OF THE SUTURE? IT IS POSSIBLE THAT THE TRACTION ON THE SUTURE WAS STRONGER THAN BEFORE, AND THE BLEEDING WAS MORE CAREFULLY STOPPED THAN BEFORE, WHICH MAY HAVE PUT A STRAIN ON THE TISSUE. WHAT WAS THE SOURCE AND TRIGGERING EVENT OF BLEEDING?¿UTERES, TORE THE TISSUE WHAT WAS THE VOLUME OF BLOOD LOSS?¿MASSIVE, BUT THE AMOUNT WAS UNK PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE.=> UNK WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)?¿NOT REPORTED WITH SPECIAL BACKGROUND. PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS.¿ RE-OPERATION (LAPAROTOMY). DISSECTION OF HEMATOMA, AND DRAINAGE. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION?¿NO WHAT IS THE SURGEON¿S EXPERIENCE WITH THE STRATAFIX SPIRAL SUTURE?¿UNK, BUT MORE THAN 4,000 CASE FOR CAESAREAN SECTION WAS THE FIXATION LOOP SECURED TO TISSUE AT THE INITIATION OF SUTURE USE DURING THE INDEX PROCEDURE?¿YES WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT?=> ""I'M NOT SURE IF SXPP1B407 IS THE DIRECT CAUSE, BUT I WAS ALWAYS WORRIED THAT THE SUTURE ENDS WOULD COME LOOSE AFTER BACKSTITCHING WITH KNOTLESS SUTURES. MAYBE I WAS PULLING THE SUTURE TOO HARD.¿ WHAT IS THE PATIENT'S CURRENT STATUS?=> THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. LOT NUMBER?¿UNK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY C-SECTION DUE TO A THREATENED MISCARRIAGE DURING HER FIRST BIRTH ON (B)(6) 2023 AND BARBED SUTURE WAS USED AND BACKSTITCHED THREE TIMES. THE SURGEON MADE A TRANSVERSE INCISION IN THE LOWER UTERINE SEGMENT. TWO LAYERS OF THE UTERUS WERE SUTURED WITH BARBED SUTURE ON THE FIRST AND SECOND LAYERS. ON (B)(6) 2024, THE PATIENT DEVELOPED A FEVER AND HAD SMALL BLEEDING FROM THE ABDOMINAL SUTURE, WHICH DID NOT SUBSIDE DESPITE THE USE OF HEMOSTATIC AGENTS. THEREFORE, THE PATIENT WAS TRANSPORTED TO THE OBSTETRICS DEPARTMENT OF A DIFFERENT HOSPITAL. THE PATIENT'S ABDOMEN WAS REOPENED, WHERE A HEMATOMA IN THE LOWER RIGHT SIDE OF THE UTERUS WAS CONFIRMED, THE HEMATOMA WAS EXCISED, AND A DRAIN WAS PLACED FOR FOLLOW-UP OBSERVATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024. ACCORDING TO THE FINDINGS OF THE SURGEON, THE DIAGNOSIS WAS VESICOUTERINE SUBSEROSAL HEMATOMA. THE SURGEON COMMENTED THAT IT WAS A PROBLEM WITH THE SUTURING METHOD. THIS WAS THE SURGEON'S FIRST EXPERIENCE WITH OVER 4,000 DELIVERIES SINCE THE CLINIC OPENED. THE SURGEON IS UNSURE IF THE BARBED SUTURE IS THE DIRECT CAUSE, BUT THE SURGEON ALWAYS WORRIED THAT THE SUTURE ENDS WOULD COME LOOSE AFTER BACKSTITCHING WITH KNOTLESS SUTURES. THE SURGEON OPINES THAT MAYBE HE WAS PULLING THE SUTURE TOO HARD. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091301 SFX SPI PDS+ UNI VIO 18IN 0 S/A CT-1 SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. 10705031236103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention