BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL

    MDR report key: 7590198 · Received June 12, 2018

    Report

    Report Number
    2210968-2018-73133
    Event Type
    Injury
    Date Received
    June 12, 2018
    Report Date
    November 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: (B)(4) 2018. IT WAS REPORTED THAT PATIENT UNDERWENT CONCURRENT TUBAL LIGATION PROCEDURE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPROPER HEALING INADEQUATE OR FAILURE OF INCORPORATION/INGROWTH, REJECTION, MESH MIGRATION, SCARIFICATION, LOSS OF ENJOYMENT OF LIFE, DISABILITY, EMOTIONAL STRESS AND CONCERN ABOUT WORK AND LOSS OF CONSORTIUM IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2014 DUE TO PAIN. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, ADHESIONS, BOWEL OBSTRUCTION, ABDOMINAL PAIN, WOUND INFECTION, RECURRENCE OF HERNIA, INFLAMMATION, ALLERGIC REACTION, EROSION, ABSCESS, FISTULA, SEROMA, NERVE DAMAGE, TISSUE DAMAGE, EMOTIONAL DISTRESS, IMPROPER HEALING INADEQUATE OR FAILURE OF INCORPORATION/INGROWTH, FOREIGN BODY RESPONSE, REJECTION, MESH MIGRATION, SCARIFICATION, GRANULOMATOUS RESPONSE, LOSS OF ENJOYMENT OF LIFE, DISABILITY, EMOTIONAL STRESS AND CONCERN ABOUT WORK AND LOSS OF CONSORTIUM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433372 ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL MESH, SURGICAL FTL ETHICON INC. DB8BGLA0

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention