BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8277259 · Received January 25, 2019

    Report

    Report Number
    2210968-2019-78572
    Event Type
    Injury
    Date Received
    January 25, 2019
    Report Date
    January 9, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K071249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: HERNIA (2016) 20 (SUPPL 1):S75¿S130. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: CLINICAL ANALYSIS AND LAPAROSCOPIC TREATMENT OF RECURRENCE AFTER OPEN INGUINAL HERNIA REPAIR". AUTHORS: CAI X. CITATION: HERNIA (2016) 20 (SUPPL 1):S75¿S130. THIS STUDY AIMED TO INVESTIGATE THE RECURRENCE OF OPEN INGUINAL HERNIA REPAIR AND THE LAPAROSCOPIC TREATMENT FOR THE RECURRENCE. FROM OCT2010 TO APR2015, 58 CASES OF RECURRENT INGUINAL HERNIA WERE REVIEWED. THIS INCLUDES 7 CASES OF INDIRECT HERNIAS, AFTER GILBERT REPAIR USING UHS, AND WERE TREATED WITH LAPAROSCOPIC REPAIR. THERE WERE DIFFERENT CHARACTERISTICS OF RECURRENCE IN EACH TYPE OF HERNIA REPAIR. LAPAROSCOPIC TREATMENT FOR RECURRENCE OF OPEN INGUINAL HERNIA REPAIR IS SAFE AND EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72585 ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention