BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8913070 · Received August 20, 2019

    Report

    Report Number
    2210968-2019-85863
    Event Type
    Injury
    Date Received
    August 20, 2019
    Report Date
    July 26, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DESCRIBED IN ARTICLE FOR (B)(6) YEAR OLD MALE IS SUBMITTED VIA MW# 2210968-2019-85862. 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. CITATION: HERNIA (2012) 16:589¿591; DOI 10.1007/S10029-011-0786-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: FIRST CASES OF GIANT PSEUDOCYST COMPLICATING INGUINAL HERNIA REPAIR. THIS STUDY AIMED TO PRESENT TWO CASES OF GIANT PSEUDOCYST COMPLICATING INGUINAL HERNIA REPAIR AND DESCRIBE ITS MANAGEMENT AND CLINICAL COURSE. A (B)(6) YEAR OLD MALE AND A (B)(6) YEAR OLD MALE UNDERWENT LICHTENSTEIN HERNIOPLASTY WITH POLYPROPYLENE (PROLENE) MESH FOR LEFT DIRECT INGUINAL HERNIA. AT 5 AND 7 MONTHS AFTER SURGERY, RESPECTIVELY, THEY DEVELOPED AN ASYMPTOMATIC SWELLING AT THE SITE OF THE SCAR THAT INCREASED OVER A PERIOD OF MONTHS. ULTRASOUND AND CT SCAN REVEALED THE PRESENCE OF A CYST WITH LIQUID CONTENT WITH NO VISIBLE RECURRENCE. BOTH PATIENTS UNDERWENT PERIODIC ASPIRATION OF THE CYST IN ANOTHER CENTER, WITH REFILLING OF IT WITHIN 3¿5 DAYS; LIQUID WAS CLEAR. AT 6 AND 10 MONTHS AFTER SURGERY, RESPECTIVELY, THE SIZE OF THE PSEUDOCYSTS WERE 10 X 6 AND 11 X 5 CM, RESPECTIVELY. BOTH PATIENTS UNDERWENT SURGERY IN WHICH INTRAOPERATIVE FINDINGS A HUGE CAPSULE THAT, WHEN OPENED, WAS FORMED BY MULTIPLE TRABECULATION AND FILLED WITH A CLEAR LIQUID. SOME SOFT AMORPHOUS WHITE-YELLOWISH MATERIAL WAS ALSO FOUND. ASPIRATION OF RESIDUAL LIQUID WAS PERFORMED, AND A BLAKE DRAIN WAS LEFT IN BOTH PATIENTS. DURING THE 1ST POST OPERATORY WEEK, THE AVERAGE VOLUME OF LIQUID DRAINED PER DAY WAS ALMOST 250 CM3 IN BOTH PATIENTS. THE 2ND WEEK IT DECREASED TO 50 CM3; THE DRAINS WERE REMOVED IN THE 3RD WEEK IN BOTH PATIENTS. AT 6 AND 10 MONTHS OF FOLLOW UP, RESPECTIVELY, NO RECURRENCE WAS FOUND IN EITHER PATIENT. THE ETIOLOGY AND PATHOGENESIS OF THE PSEUDOCYST FORMATION REMAIN UNCERTAIN, AND ITS INCIDENCE HAS NOT YET BEEN WELL DOCUMENTED. SOME AUTHORS SUPPORT THE HYPOTHESIS THAT PSEUDOCYST COULD BE SECONDARY TO SEROMA FORMATION, OR A HEMATOMA THAT LATER MATURED INTO A CYST. AS DESCRIBED PREVIOUSLY, IT APPEARS THAT MESH IS STRONGLY ASSOCIATED WITH THE DEVELOPMENT OF THE PSEUDOCYST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704970 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention