BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PVP SMALL 4.3CM X 4.3CM

    MDR report key: 10430555 · Received August 20, 2020

    Report

    Report Number
    2210968-2020-06169
    Event Type
    Injury
    Date Received
    August 20, 2020
    Report Date
    August 17, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    UDI-DI
    10705031132412
    PMA / PMN Number
    K061533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 03/23/2021. ADDITIONAL B5 NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2014 DUE TO RECURRENT UMBILICAL HERNIA AND ADHESIONS. DATE SENT TO THE FDA: 03/23/2021. CORRECTED B5 NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF UMBILICAL HERNIA ON (B)(6) 2014 AND MESH WAS IMPLANTED.

    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 HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION AND LOSS OF APPETITE. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896091 PVP SMALL 4.3CM X 4.3CM MESH, SURGICAL, POLYMERIC FTL ETHICON INC. PVPS 10705031132412

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention