BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 24422983 · Received February 23, 2026

    Report

    Report Number
    2210968-2026-01891
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    November 13, 2025
    Report Date
    February 23, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. 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: J PEDIATR SURG. 2026 FEB;61(2):162810. HTTPS://DOI.ORG/10.1016/J.JPEDSURG.2025.162810. EPUB 2025 NOV 13. PMID: 41241138.

    Description of Event or Problem · 0

    TITLE: PEDIATRIC INGUINAL HERNIA REPAIR WITH LAPAROSCOPY (PIHRL)-TRIAL: A MULTICENTER STUDY COMPARING EXTRA-CORPOREAL PERCUTANEOUS INTERNAL RING SUTURING (PIRS) AND INTRA-CORPOREAL PURSE-STRING SUTURE FOR INGUINAL HERNIA. THE AIM OF THIS TRIAL IS TO COMPARE OUTCOMES, E. G. RECURRENCE AND ANESTHESIA TIMES, OF PIRS WITH INTRA-CORPOREAL LAPAROSCOPY USING A PURSE-STRING SUTURE (LIHR). IN TOTAL, 177 SUBJECTS WERE INCLUDED; 56 UNDERWENT IHR WITH PIRS IN THE MUMC+ IN MAASTRICHT (MPIRS-GROUP), 70 UNDERWENT IHR WITH PIRS IN THE UCHW IN WROCLAW (WPIRS-GROUP) AND 51 UNDERWENT LIHR. ALL (PARENTS/GUARDIANS OF) PATIENTS WERE CONTACTED FOR THE FOLLOW-UP MOMENTS AT THREE WEEKS AND ONE YEAR AFTER SURGERY. THREE SUBJECTS WERE LOST TO FOLLOW-UP: TWO DID NOT WANT TO PARTICIPATE ANYMORE AND ONE WAS TAKEN INTO FOSTER CARE, MEANING 54 SUBJECTS WERE LEFT IN THE MPIRS-GROUP, 70 IN THE WPIRS-GROUP AND 50 IN THE LIHR-GROUP. PIRS WITH INTRA-CORPOREAL LAPAROSCOPY USING A PURSE-STRING SUTURE (LIHR). THE ANTERIOR ABDOMINAL WALL WAS PUNCTURED OVER THE AREA OF THE INTERNAL INGUINAL RING WITH AN 18 GAUGE NEEDLE, WITH A LOOP OF MONOFILAMENT POLYDIOXANONE SUTURE (PDS) IN THE BARREL OF THE NEEDLE. THE NEEDLE WITH THE LOOP WAS MANEUVERED ALONG ONE-HALF OF THE INTERNAL RING, IN BETWEEN THE PERITONEUM AND THE FASCIA. THEN THE NEEDLE WAS REMOVED AND THE PDS LOOP WAS LEFT INTRA-ABDOMINALLY. WITH A NON-ABSORBABLE MULTIFILAMENT SUTURE (MERSILENE) IN THE BARREL, THE SAME NEEDLE WAS REINSERTED THROUGH THE SAME TRANSCUTANEOUS PUNCTURE HOLE AND MANEUVERED ALONG THE OTHER HALF OF THE INTERNAL RING. SPECIAL ATTENTION WAS PAID TO THE SPERMATIC CORD IN BOYS, AS NOT TO PUNCTURE OR ENTRAP IT. THE TIP OF THE MERSILENE SUTURE WAS PLACED THROUGH THE PDS LOOP, LEAVING BOTH SUTURES IN PLACE WHILE REMOVING THE NEEDLE. THE PDS LOOP WAS PULLED OUT, CREATING A PURSE STRING SUTURE AROUND THE INTERNAL ANNULUS WITH THE MERSILENE SUTURE. THE MERSILENE WAS KNOTTED EXTRA-CORPOREALLY AND THE KNOT WAS BURIED SUBCUTANEOUSLY. THE CONTRALATERAL SIDE WAS EXPLORED WITH THE CAM ERA. IN CASE OF A PATENT PROCESSUS VAGINALIS, THIS WAS CLOSED WITH THE SAME TECHNIQUE AS DESCRIBED ABOVE. THE INFRA-UMBILICAL INCISION WAS CLOSED WITH AN ABSORBABLE SUTURE. THE NEEDLE AND SUTURE WERE INTRODUCED INTO THE ABDOMINAL CAVITY. AN ABSORBABLE MULTIFILAMENT SUTURE (VICRYL) WAS USED. THE SUTURE IS WOVEN THROUGH THE PERITONEUM, AROUND THE INTERNAL ANNULUS. GREAT CARE WAS TAKEN TO PRESERVE AND NOT ENTRAP THE SPERMATIC CORD IN BOYS. THE SUTURE WAS KNOTTED INTRA-CORPOREALLY, CREATING A PURSE STRING SUTURE AT THE BASE OF THE INTERNAL RING. REPORTED COMPLICATIONS INCLUDE: PATIENT INFORMATION: PDS (ETHICON) TESTICULAR ATROPHY (N=1) TREATMENT: NOT REPORTED SUTURE FISTULAS (N=2) TREATMENT: RE-INTERVENTION UNDER GENERAL ANESTHESIA FIBROMA (N=1) TREATMENT: RE-INTERVENTION UNDER GENERAL ANESTHESIA UMBILICAL INFECTION (N=1) TREATMENT: NOT REPORTED. VICRYL (ETHICON) SUBCUTANEOUS HEMORRHAGE OF THE SURGICAL SITE WITH A DECREASED HB (N=1) TREATMENT: RE-ADMISSION. MERSILENE (ETHICON) TESTICULAR ATROPHY (N=1) TREATMENT: NOT REPORTED SUTURE FISTULAS (N=2) TREATMENT: RE-INTERVENTION UNDER GENERAL ANESTHESIA FIBROMA (N=1) TREATMENT: RE-INTERVENTION UNDER GENERAL ANESTHESIA UMBILICAL INFECTION (N=1) TREATMENT: NOT REPORTED. IN CONCLUSION, THIS MULTICENTER PROSPECTIVE CLINICAL TRIAL REINFORCES THE EXIST ING EVIDENCE THAT PIRS IS A SAFE AND VIABLE SURGICAL OPTION FOR PEDIATRIC IHR. FURTHERMORE, OUR FINDINGS SHOW THAT IT MIGHT BE AN ALTERNATIVE FOR INTRA-CORPOREAL LIHR, AS BOTH ANESTHESIA TIMES AND THE RECURRENCE RATE WERE SIGNIFICANTLY LOWER IN THE PIRS GROUP ONE YEAR POST-OPERATIVELY. HOWEVER, EVEN THOUGH NOT SIGNIFICANT, THERE WERE MORE RE-INTERVENTIONS UNDER GENERAL ANESTHESIA IN THE PIRS GROUP NECESSARY. ADDITIONALLY, THE DIFFERENCE IN AGE BETWEEN BOTH GROUPS NEEDS TO BE TAKEN INTO ACCOUNT AND IS SOMETHING THAT IN FUTURE PROSPECTIVE STUDIES BETWEEN BOTH LAPAROSCOPIC TECHNIQUES NEEDS TO BE PREVENTED. THEREFORE, RANDOMIZED CLINICAL TRIALS ARE NECESSARY TO PROVE THE VALUE OF THE PIRS TECHNIQUE, ALSO IN THE SMALLEST CHILDREN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478804 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention