BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH UNKNOWN PRODUCT

    MDR report key: 7496293 · Received May 8, 2018

    Report

    Report Number
    2210968-2018-72664
    Event Type
    Injury
    Date Received
    May 8, 2018
    Report Date
    April 10, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    TITLE: LONG-TERM ASSESSMENT OF SURGICAL AND QUALITY OF LIFE OUTCOMES BETWEEN LIGHTWEIGHT (ULTRAPRO) AND HEAVYWEIGHT (STANDARD 3DMAXTM) MESH IN LAPAROSCOPIC INGUINAL HERNIA REPAIR THE AIM OF THIS STUDY WAS TO COMPARE SURGICAL AND QUALITY OF LIFE (QOL) OUTCOMES BETWEEN LIGHTWEIGHT MESH (LWM; ULTRAPRO MESH) AND HEAVYWEIGHT MESH (HWM; STANDARD 3DMAXTM) UTILIZED IN LAPAROSCOPIC INGUINAL HERNIA REPAIR (LIHR). A PROSPECTIVE, SINGLE-CENTER, HERNIA-SPECIFIC DATABASE/STUDY WAS PERFORMED FOR ALL ADULT LIHR FROM 1999 TO MAY 2015. A TOTAL OF 692 PATIENTS WERE REPAIRED WITH LWM (ULTRAPRO MESH) AND 391 PATIENTS WITH HWM (STANDARD 3DMAXTM). THE LWM PATIENTS WERE YOUNGER (51.9I14.7 VERSUS 54.1+/-14.5YEARS; P<0.001). IN THE LWM GROUP, REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE SEROMA (30.1%), SYMPTOMATIC DISCOMFORT (57.1%) 2 WEEKS POST-SURGERY, AND MORE MESH SENSATION (12.4%) 24 MONTHS POST-SURGERY. IT WAS CONCLUDED THAT THOSE WHO HAD LWM WERE YOUNGER AND LESS CO-MORBID, BUT HAD MORE POST-OPERATIVE SEROMA FORMATION. LWM WAS ASSOCIATED WITH GREATER DISCOMFORT AT 2 WEEKS AND MORE MESH SENSATION AT 24 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336140 ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1