BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE

    MDR report key: 24679811 · Received March 24, 2026

    Report

    Report Number
    2210968-2026-02979
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    December 22, 2025
    Report Date
    March 24, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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: PEDIATR SURG INT. 2025 DEC 22;42(1):49. HTTPS://DOI.ORG/10.1007/S00383-025-06273-7 PMID: 41428088.

    Description of Event or Problem · 0

    TITLE: OPEN VERSUS LAPAROSCOPIC INDIRECT INGUINAL HERNIA REPAIR IN CHILDREN: A TEN-YEAR RETROSPECTIVE REVIEW OF LAPAROSCOPIC PERCUTANEOUS INTERNAL RING SUTURING. THE PURPOSE OF THIS STUDY IS TO COMPARE THE OUTCOMES OF LAPAROSCOPIC PERCUTANEOUS INTERNAL RING SUTURING WITH PERITONEAL THERMAL INJURY TO OPEN REPAIRS FROM 2014 TO 2023. 1,141 CHILDREN WERE INCLUDED, OF WHICH 61.5% (N = 702) HAD AN OPEN REPAIR AND 38.5% (N = 439) HAD A LAPAROSCOPIC REPAIR. ETHIBOND (ETH) WHICH WAS USED TO UTILIZED FOR LAPAROSCOPIC REPAIR, WHILE ABSORBABLE BRAIDED POLYGLACTIN 910 SUTURE (I.E. VICRYL) WAS MOST OFTEN USED IN OPEN REPAIRS. NYLON (ETH), PROLENE (ETH), AND SILK (ETH) WERE USED AS A SUTURE MATERIAL IN THE OPEN INGUINAL HERNIA REPAIR GROUP. PDS (ETH) WAS USED IN BOTH GROUPS. REPORTED COMPLICATIONS: LAPAROSCOPIC GROUP (N=439) PDS (ETH) ETHIBOND (ETH). SURGICAL SITE INFECTION (N=6) TREATMENT: NOT REPORTED. HEMATOMA (N=1) TREATMENT: NOT REPORTED. SYMPTOMATIC HYDROCELE (N=1) TREATMENT: NOT REPORTED. PORT SITE HERNIA (N=1) TREATMENT: NOT REPORTED. HERNIA RECURRENCE (N=11) TREATMENT: NOT REPORTED. METACHRONOUS HERNIAS (N=3) TREATMENT: INITIAL REPAIR. SECOND IHR OPERATION (N=13) TREATMENT: NOT REPORTED. OPEN REPAIR GROUP (N=702) ETHIBOND (ETH) NYLON (ETH) PDS (ETH) PROLENE (ETH) SILK (ETH) VICRYL (ETH) SURGICAL SITE INFECTION (N=8) TREATMENT: NOT REPORTED. HEMATOMA (N=6) TREATMENT: ONE REQUIRED DRAINAGE. PORT-SITE HERNIA (N=1) TREATMENT: NOT REPORTED. TESTICULAR ATROPHY (N=1) TREATMENT: NOT REPORTED. HERNIA RECURRENCE (N=8) TREATMENT: NOT REPORTED. SEROMA (N=1) TREATMENT: NOT REPORTED. METACHRONOUS HERNIAS (N=14) TREATMENT: FIVE CHILDREN RECEIVED TRANS-UMBILICAL LAPAROSCOPIC EVALUATION OF THE CONTRALATERAL SIDE AT THE TIME OF THEIR INITIAL REPAIR, WHILE NINE RECEIVED NO EVALUATION. SYMPTOMATIC HYDROCELE (N=3) TREATMENT: NOT REPORTED. SECOND IHR OPERATION (N=21) TREATMENT: NOT REPORTED. IN CONCLUSIONS, NO SIGNIFICANT DIFFERENCE IN OUTCOMES BETWEEN THE LAPAROSCOPIC PIRS WITH PTI AND HYDRODISSECTION TECHNIQUE AND OPEN TECHNIQUE IN PEDIATRIC IHR, WHICH INCLUDED RECURRENT HERNIA, METACHRONOUS, CONTRALATERAL HER NIA, NEED FOR SECOND INGUINAL HERNIA OPERATION, AND POST-OPERATIVE COMPLICATION. THE LAPAROSCOPIC TECHNIQUE HAD EXCELLENCE INTRA-OPERATIVE SAFETY WITHOUT COMPLICATION AND RARE NEED TO CONVERT TO AN OPEN APPROACH. HERNIA RECURRENCE AND POST-OPERATIVE COMPLICATIONS WERE VERY INFREQUENT WITH THE LAPAROSCOPIC TECHNIQUE. THIS SHOULD PROVIDE SUPPORT FOR CONTINUED USE OF THE LAPAROSCOPIC PIRS WITH PTI AND HYDRODISSECTION IN REPAIR OF INGUINAL HERNIAS IN THE PEDIATRIC POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742224 PDS II POLYDIOXANONE SUTURE SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention