BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7926847 · Received October 2, 2018

    Report

    Report Number
    2210968-2018-76214
    Event Type
    Injury
    Date Received
    October 2, 2018
    Report Date
    September 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: HERNIA. 2015; 19: 909¿914. DOI: 10.1007/S10029-015-1360-Y (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: RESULTS OF PROSTHETIC MESH REPAIR IN THE EMERGENCY MANAGEMENT OF THE ACUTELY INCARCERATED AND/OR STRANGULATED GROIN HERNIAS: A 10-YEAR STUDY" AUTHOR: S. S. BESSA ¿ M. R. ABDEL-FATTAH ¿ I. A. AL-SAYES ¿ I. T. KORAYEM TITLE: RESULTS OF PROSTHETIC MESH REPAIR IN THE EMERGENCY MANAGEMENT OF THE ACUTELY INCARCERATED AND/OR STRANGULATED GROIN HERNIAS: A 10-YEAR STUDY AUTHORS: S. S. BESSA, M. R. ABDEL-FATTAH, I. A. AL-SAYES, I. T. KORAYEM CITATION: HERNIA. 2015; 19: 909¿914. DOI: 10.1007/S10029-015-1360-Y THE AIM OF THIS PROSPECTIVE STUDY WAS TO PRESENT A 10-YEAR EXPERIENCE WITH THE USE OF PROSTHETIC MESH REPAIR IN THE MANAGEMENT OF THE ACUTELY INCARCERATED AND/OR STRANGULATED GROIN HERNIAS. A TOTAL OF 234 PATIENTS (212 MALE AND 22 FEMALE PATIENTS; AGE RANGE: 16 TO 85 YEARS OLD; BMI: 25 TO 34) WITH ACUTELY INCARCERATED AND/OR STRANGULATED GROIN HERNIAS WERE TREATED BY EMERGENCY REPAIR OF THE HERNIA USING A PROLENE MESH (ETHICON). DURING THE SURGICAL PROCEDURE FOR INGUINAL HERNIAS, A LICHTENSTEIN TENSION-FREE REPAIR WITH THE USE OF A PROLENE MESH (ETHICON) WAS UTILIZED IN ALL PATIENTS. FOR FERMORAL HERNIAS, AN INGUINAL APPROACH WAS USED IN ALL PATIENTS. THE RESECTION¿ ANASTOMOSIS OF NON-VIABLE BOWEL WAS PERFORMED IN A SINGLE LAYER SERO-MUSCULAR EXTRA-MUCOSAL MANNER USING INTERRUPTED VICRYL 3-0 SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N-14) WHICH REQUIRED APPROPRIATE ANTIBIOTICS GUIDED BY CULTURE AND SENSITIVITY STUDIES, SCROTAL HEMATOMA (N-9) WHICH WAS TREATED ACCORDING TO STANDARD MEASURES, MESH INFECTION (N-1) WHICH NECESSITATED REMOVAL OF THE MESH, AND RECURRENCES (N-2). IT WAS CONCLUDED THAT FROM THE PRESENT 10 YEARS STUDY, THE USE OF PROSTHETIC MESH REPAIR IN THE EMERGENCY MANAGEMENT OF THE ACUTELY INCARCERATED AND/OR STRANGULATED GROIN HERNIAS IS SAFE, IS NOT ASSOCIATED WITH EITHER MAJOR SYSTEMIC OR MESH-RELATED COMPLICATIONS AND IS ASSOCIATED WITH LOW RECURRENCE RATE, AND THE PRESENCE OF INTESTINAL ISCHEMIA OR NECROSIS AND THUS THE NECESSITY TO PERFORM INTESTINAL RESECTION CANNOT BE CONSIDERED A CONTRAINDICATION FOR PROSTHETIC MESH REPAIR .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766542 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention