BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7607034 · Received June 15, 2018

    Report

    Report Number
    2210968-2018-73510
    Event Type
    Injury
    Date Received
    June 15, 2018
    Report Date
    May 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. WAS THERE EVIDENCE THAT LED SURGEON TO BELIEVE THE ETHICON PRODUCT WAS COUNTERFEIT? CITATION: HERNIA (2010) 14:313¿315; DOI 10.1007/S10029-009-0536-8 - [(B)(4) - SHAMIM 2010 (1).PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: RECURRENT INGUINAL HERNIA DUE TO MESH DISSOLUTION: TWO CASE REPORTS" AUTHOR: M. SHAMIM CITATION: HERNIA (2010) 14:313¿315; DOI 10.1007/S10029-009-0536-8. THE AUTHOR PRESENTED TWO CASES OF INGUINAL HERNIA RECURRENCES AFTER MESH HERNIOPLASTY. THE SECOND CASE REPORT WAS A (B)(6)-YEAR-OLD MALE PATIENT WHO HAD RECURRENT LEFT INGUINAL HERNIA 3 YEARS AFTER HIS UNCOMPLICATED LEFT INGUINAL HERNIA, IN WHICH (PROLENE) MESH HERNIOPLASTY. ON EXAMINATION, THERE WAS AN ABSENCE OF ANY PROLENE MESH OVER THE POSTERIOR INGUINAL WALL, THOUGH ANCHORING INTERRUPTED PROLENE SUTURES WERE IN PLACE. AS A TREATMENT, HERNIOTOMY WAS PERFORMED WITH MODIFIED LICHTENSTEIN¿S REPAIR. THE POST-OPERATIVE PERIOD WAS UNEVENTFUL. IN THIS REPORT, THE CAUSE OF RECURRENCE WAS THE ABSORPTION OR DISSOLUTION OF NON-ABSORBABLE POLYPROPYLENE (PROLENE) MESH. A COUNTERFEIT VERSION OF ETHICON¿S PROLENE (POLYPROPYLENE) MESH HAS BEEN KNOWN TO BE DISTRIBUTED TO USA HOSPITALS AND USED IN PATIENTS UNDERGOING TENSION-FREE HERNIA REPAIR. THE IMPLANTATION OF COUNTERFEIT/PIRATED PROLENE POLYPROPYLENE MESH CAN LEAD TO ADVERSE EVENTS SUCH AS RECURRENCES (FROM COMPLETE DISSOLUTION/ABSORPTION). THE SURGEONS DEALING WITH HERNIAS SHOULD KNOW THE DIFFERENCE BETWEEN ORIGINAL AND PIRATED PROLENE MESH. ADDITIONAL REINFORCEMENT OF THE POSTERIOR WALL OF THE INGUINAL CANAL CAN BE DONE IN CASES OF DOUBT IN ORDER TO AVOID RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449891 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention