BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7676945 · Received July 11, 2018

    Report

    Report Number
    2210968-2018-74231
    Event Type
    Injury
    Date Received
    July 11, 2018
    Report Date
    June 18, 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? CITATION: HERNIA. 2013; 17: 59¿65. DOI: 10.1007/S10029-012-0938-X. [(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 VENTRAL HERNIAS: A SEVEN YEARS STUDY. AUTHORS: S. S. BESSA, A. H. ABDEL-RAZEK. CITATION: HERNIA. 2013; 17: 59¿65. DOI: 10.1007/S10029-012-0938-X. THE AIM OF THIS PROSPECTIVE STUDY WAS TO PRESENT A 7-YEAR EXPERIENCE WITH THE USE OF PROSTHETIC MESH REPAIR IN THE MANAGEMENT OF THE ACUTELY INCARCERATED AND/OR STRANGULATED VENTRAL HERNIAS. THE PRESENT STUDY INCLUDED 80 PATIENTS (65 FEMALE AND 15 MALE PATIENTS; BMI: 26 TO 38) WITH ACUTELY INCARCERATED AND/OR STRANGULATED VENTRAL HERNIAS. THEIR AGE RANGED FROM 25 TO 86 YEARS WITH A MEAN OF 56.1 ± 13.2 YEARS. THE HERNIA WAS PARA-UMBILICAL IN 71 PATIENTS, EPIGASTRIC IN 6 PATIENTS, AND INCISIONAL IN 3 PATIENTS. DURING THE SURGICAL PROCEDURE, FOLLOWING EXCISION OF THE SAC AND DEALING WITH ITS CONTENTS, THE DEFECT WAS VERTICALLY CLOSED BY SIMPLE INTERRUPTED NON-ABSORBABLE PROLENE 1-0 SUTURES. NEXT, THE SKIN AND SUBCUTANEOUS FLAPS WERE ELEVATED TO FIT A 15 × 15 CM MONOFILAMENT PROLENE MESH. THE MESH WAS FIXED TO THE ABDOMINAL WALL MUSCLES AS AN ONLAY PATCH USING INTERRUPTED PROLENE 2-0 NON-ABSORBABLE SUTURES. THE CENTER OF THE MESH OVERLAID THE CLOSED ABDOMINAL WALL DEFECT. THE RESECTION-ANASTOMOSIS OF NON-VIABLE BOWEL WAS PERFORMED IN A SINGLE-LAYER SERO-MUSCULAR EXTRA-MUCOSAL MANNER USING INTERRUPTED VICRYL 3-0 ABSORBABLE SUTURES. REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N-9) WHICH WERE TREATED BY APPROPRIATE ANTIBIOTICS GUIDED BY CULTURE AND SENSITIVITY STUDIES, OPENING ONE OR TWO STITCHES FOR DRAINAGE AND FREQUENT DRESSINGS, SEROMA (N-5) WHICH REQUIRED RE-INSERTION OF A CATHETER TUBE DRAIN UNDER LOCAL ANESTHESIA FOR AN EXTRA 7¿14 DAYS, AND MESH INFECTION (N-1) WHICH NECESSITATES MESH REMOVAL. IT WAS CONCLUDED THAT THE USE OF PROSTHETIC MESH REPAIR IN THE EMERGENCY MANAGEMENT OF THE ACUTELY INCARCERATED AND/OR STRANGULATED VENTRAL HERNIAS IS SAFE. THE PRESENCE OF NON-VIABLE INTESTINE CANNOT BE REGARDED AS A CONTRAINDICATION FOR PROSTHETIC REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519624 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROLENE, VICRYL SUTURE