BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON PHYSIOMESH OPEN

    MDR report key: 8726650 · Received June 24, 2019

    Report

    Report Number
    2210968-2019-83094
    Event Type
    Injury
    Date Received
    June 24, 2019
    Report Date
    September 25, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K141560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODES: 2240,2330,1695,1930,1994,3191 - BULGING. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HERNIA RECURRENCE, PAIN, DISCOMFORT, BULGING, ADHESION AND INFECTION FOLLOWING SURGERY. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2016. IN ADDITION, A DEVICE HISTORY REVIEW HAS BEEN INSERTED INTO THE FILE. THIS REVIEW INDICATES THAT THERE WAS NO QUALITY CONCERNS ASSOCIATED WITH THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2016 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2014 WHICH IS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523273 ETHICON PHYSIOMESH OPEN MESH, SURGICAL FTL ETHICON INC. HM9GQDZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention