BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8913421 · Received August 20, 2019

    Report

    Report Number
    2210968-2019-85876
    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). 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. CITATION: WORLD J SURG (2010) 34:3059¿3064; DOI 10.1007/S00268-010-0730-Y. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC (TEP) VERSUS LICHTENSTEIN INGUINAL HERNIA REPAIR: A COMPARISON OF QUALITY-OF-LIFE OUTCOMES" AUTHOR/S: EDDIE MYERS ¿ KATHERINE M. BROWNE ¿ DARA O. KAVANAGH ¿ MICHAEL HURLEY CITATION: WORLD J SURG (2010) 34:3059¿3064; DOI 10.1007/S00268-010-0730-Y. THIS CASE-MATCHED, RETROSPECTIVE REVIEW OF DATABASE STUDY AIMED TO COMPARE THE QUALITY-OF-LIFE OUTCOMES FOLLOWING LAPAROSCOPIC VERSUS OPEN REPAIR OF INGUINAL HERNIA. BETWEEN JAN1999 AND DEC2006, 314 REPAIRS OF UNILATERAL PRIMARY INGUINAL HERNIAS WERE PERFORMED VIA THE TOTALLY EXTRAPERITONEAL ROUTE (TEP) OR LICHTENSTEIN REPAIRS (LR) AND WERE FURTHER CASE-MATCHED: TEP (N=90; N=86 MALE AND N=4 FEMALE; MEDIAN AGE OF 54 YEARS [RANGED 4271 YEARS]) AND LR (N=90; N=86 MALE AND N=4 FEMALE; MEDIAN AGE OF 56 YEARS [RANGED 43-75 YEARS]). IN TEP REPAIR, A 10 X 15 KNITTED PROLENE MESH WAS USED. TACKS WERE USED TO FIX THE MESH ONLY WHEN A DIRECT HERNIA WAS ENCOUNTERED. IN BOTH REPAIRS, SKIN CLOSURE WAS ACHIEVED USING SUBCUTANEOUS MONOCRYL. THE PERIUMBILICAL FASCIAL DEFECT WAS CLOSED WITH VICRYL. IN TEP GROUP, POSTOPERATIVE COMPLICATIONS INCLUDED RECURRENCE (N=3), DYSESTHESIS (N=9), CHRONIC PAIN (N=3), TECHNICAL FAILURE (N=1), AND HEMATOMA/SEROMA (N=6). IN LR GROUP, POSTOPERATIVE COMPLICATIONS INCLUDED DYSESTHESIS (N=27), CHRONIC PAIN (N=9), WOUND INFECTION (N=2) AND HEMATOMA/SEROMA (N=2). THIS STUDY REITERATES THE EQUIVALENCE OF TEP REPAIR WITH OPEN REPAIR IN TERMS OF RECURRENCE, WITH IMPROVED POSTOPERATIVE DYSESTHESIA AND CHRONIC PAIN RATES. IN ADDITION, QUALITY OF LIFE IS SIGNIFICANTLY IMPROVED FOLLOWING TEP VERSUS LICHTENSTEIN REPAIR IN TERMS OF NOT ONLY POSTOPERATIVE PAIN AND RETURN TO FUNCTIONAL STATUS, BUT IN PHYSICAL ROLE, GENERAL HEALTH, AND EMOTIONAL ROLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706138 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention