BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY

    MDR report key: 12530258 · Received September 24, 2021

    Report

    Report Number
    2210968-2021-08859
    Event Type
    Injury
    Date Received
    September 24, 2021
    Report Date
    September 22, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K180829
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 10/31/2021. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 10/25/2021. ADDITIONAL B5 NARRATIVE: IT WAS REPORTED THAT THE PATIENT EXPERIENCED HERNIA RECURRENCE, PAIN FOLLOWING THE SURGERY. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2013. DATE SENT TO THE FDA: 10/25/2021. CORRECTED INFORMATION: G1 - MANUFACTURING SITE NAME AND ADDRESS.

    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) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426805 PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY MESH, SURGICAL, POLYMERIC FTL ETHICON INC. 22496-38

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention