BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH UNKNOWN PRODUCT

    MDR report key: 23927741 · Received December 30, 2025

    Report

    Report Number
    2210968-2025-14711
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    July 29, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: 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? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. CITATION: CITATION: SURGICAL ENDOSCOPY (2025) 39:5889¿5898. DOI: HTTPS://DOI.ORG/10.1007/S00464-025-11913-Z.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF OPEN AND LAPAROSCOPIC PREPERITONEAL TENSION-FREE REPAIR OF GROIN HERNIA: A PROSPECTIVE NONRANDOMIZED CONTROLLED STUDY. THE AIM OF THIS STUDY IS TO COMPARE THE OUTCOMES OF OPEN AND LAPAROSCOPIC PREPERITONEAL GROIN HERNIA REPAIR IN (B)(6) PATIENTS WHO UNDERWENT EITHER OPEN OR LAPAROSCOPIC PREPERITONEAL HERNIORRHAPHY IN THE DEPARTMENT BETWEEN OCTOBER 2016 AND DECEMBER 2019, FOLLOWING THE ESTABLISHED INCLUSION AND EXCLUSION CRITERIA. OF THESE, (B)(6) PATIENTS UNDERWENT OPEN PREPERITONEAL PROCEDURES, WHILE (B)(6) PATIENTS UNDERWENT LAPAROSCOPIC PREPERITONEAL PROCEDURES. ULTRAPRO HERNIA SYSTEM (ETH) WAS USED TO PERFORMED IN THE OPEN PREPERITONEAL REPAIRS, WHILE ULTRAPRO MESH WAS USED TO APPLIED IN THE TAPP AND TEP PROCEDURES. REPORTED COMPLICATIONS: OPEN PROCEDURE (N=290). ULTRAPRO HERNIA SYSTEM. FEMORAL VASCULAR INJURY (N=1). TREATMENT: NOT REPORTED. HUGE HEMATOMA (N=1). TREATMENT: CONSERVATIVE TREATMENT FOR >1 WEEK. PREPERITONEAL HEMATOMA (N=2). TREATMENT: CONSERVATIVE TREATMENT. WOUND INFECTIONS (N=3). TREATMENT: DEBRIDEMENT. MODERATE PAIN WITH MILD PAIN-RELATED INTERFERENCE (N=1). TREATMENT: NOT REPORTED. TESTIS ATROPHY (N=1). TREATMENT: NOT REPORTED. SEROMA (N=13). TREATMENT: NOT REPORTED. HEMATOMA (N=2). TREATMENT: CONSERVATIVE TREATMENT. INTESTINAL INJURY (N=1). TREATMENT: IMMEDIATELY REPAIRED. RECURRENCE (N=2). TREATMENT: NOT REPORTED. LIHR PROCEDURE (N=848). ULTRAPRO MESH. FEMORAL VASCULAR INJURY (N=1). TREATMENT: IMMEDIATELY SUTURED. SMALL INTESTINAL INJURY (N=2). TREATMENT: NOT REPORTED. DRAINAGE FLUID WITH CONCURRENT FEVER (N=1). TREATMENT: LAPAROTOMY. ILEAL PERFORATION (N=1). TREATMENT: WAS IMMEDIATELY REPAIRED. SEROMA (N=51). TREATMENT: NOT REPORTED. PREPERITONEAL HEMATOMA (N=4). TREATMENT: CONSERVATIVE TREATMENT. DELAYED TROCAR SITE HEALING (N=1). TREATMENT: NOT REPORTED. INTESTINAL OBSTRUCTION (N=1). TREATMENT: EMERGENCY OPERATION WAS PERFORMED. RECURRENCE (N=5). TREATMENT: NOT REPORTED. IN CONCLUSION, BOTH OPEN AND LAPAROSCOPIC PROCEDURES ARE SAFE AND EFFECTIVE FOR GROIN HERNIA PREPERITONEAL HERNIORRHAPHY, WITH LOW INCIDENCE RATES OF LIFE-THREATENING COMPLICATIONS AND RECURRENCE. THE LAPAROSCOPIC APPROACH IS SUPERIOR IN TERMS OF LOWER INCIDENCE RATES OF INFECTION AND FASTER RECOVERY BUT COSTS MORE THAN THE OPEN APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197080 ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention