BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 22608494 · Received July 25, 2025

    Report

    Report Number
    2210968-2025-08588
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    March 8, 2025
    Report Date
    July 25, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: CUREUS. 2025 MAR 8;17(3):E80242. HTTPS://DOI.ORG/10.7759/CUREUS.80242 PMID: 40061848; PMCID: PMC11890591.

    Description of Event or Problem · 0

    TITLE: CRITICAL CONSIDERATIONS IN EMERGENCY REPAIR OF GIANT BILATERAL INGUINOSCROTAL HERNIAS. THIS IS A CASE STUDY OF A 87-YEAR-OLD MAN PRESENTED WITH AN EIGHT-HOUR HISTORY OF ACUTE SEVERE RIGHT SCROTAL PAIN AND VOMITING, WITHOUT ASSOCIATED ABDOMINAL PAIN. THE PATIENT UNDERWENT EMERGENCY SURGERY OF GIANT BILATERAL INGUINOSCROTAL HERNIAS USING 3/0 VICRYL AND 1/0 POLYDIOXANONE (PDS) SUTURES. REPORTED COMPLICATIONS ARE N=1; 87-YEAR-OLD MAN SUPERFICIAL WOUND INFECTION. TREATMENT: ELECTROLYTE REPLACEMENT AND ANTIBIOTICS. IN CONCLUSION, GIANT BILATERAL INGUINOSCROTAL HERNIAS POSE SIGNIFICANT SURGICAL CHALLENGES, ESPECIALLY IN EMERGENCY SETTINGS. THIS CASE UNDERSCORES THE IMPORTANCE OF CAREFUL RISK ASSESSMENT, OPERATIVE PLANNING, AND VIGILANT POSTOPERATIVE CARE. THE RIVES-STOPPA REPAIR PROVIDES A DURABLE SOLUTION FOR EXTENSIVE DEFECTS, MINIMIZING RECURRENCE AND RESTORING THE ABDOMINAL DOMAIN. GREATER AWARENESS AND TRAINING ARE ESSENTIAL TO IMPROVE OUTCOMES IN THESE RARE AND COMPLEX CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2382787 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention