BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 25093886 · Received May 6, 2026

    Report

    Report Number
    2210968-2026-04949
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    September 30, 2025
    Report Date
    May 6, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: INTERNATIONAL JOURNAL OF LIFE SCIENCES, BIOTECHNOLOGY AND PHARMA RESEARCH VOL. 14, NO. 9, SEPTEMBER 2025. HTTPS://DOI.ORG/10.69605/IJLBPR_14.9.2025.243 PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: EVALUATION OF PARAUMBILICAL HERNIA: SURGICAL TECHNIQUES AND POSTOPERATIVE OUTCOMES IN A TERTIARY CARE SETTING THE AIM OF THIS STUDY IS TO EVALUATE THE CLINICAL PROFILE, SURGICAL MANAGEMENT, AND POSTOPERATIVE OUTCOMES OF 50 PUH PATIENTS AT A TERTIARY CARE CENTER FROM JANUARY TO DECEMBER 2023. PROLENE (ETH) WAS USED TO CLOSED THE DEFECT OF HERNIA CONTENTS, WHILE 2-0 PROLENE MESH (ETH) WAS USED TO PLACE OVER THE ANTERIOR RECTUS SHEATH. REPORTED COMPLICATIONS: PROLENE SUTURE (ETH). PROLENE MESH (ETH). WOUND INFECTION (N=5). TREATMENT: NOT REPORTED. SEROMA (N=6). TREATMENT: NOT REPORTED. RECURRENCE (N=2). TREATMENT: NOT REPORTED. IN CONCLUSION, PUH PREDOMINANTLY AFFECTS MIDDLE-AGED ADULTS, WITH FEMALE PREDOMINANCE. MESH BASED REPAIRS, WHETHER OPEN OR LAPAROSCOPIC, ARE SAFE AND EFFECTIVE, WITH LOW COMPLICATION AND RECURRENCE RATES. LAPAROSCOPIC IPOM PROVIDES ADVANTAGES IN RECOVERY AND COSMESIS, WHILE OPEN MESH REPAIR REMAINS RELIABLE FOR LARGER DEFECTS. ANATOMICAL REPAIR MAY BE RESERVED FOR SMALL DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526447 PROLENE POLYPROPYLENE SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other