BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 10006362 · Received April 28, 2020

    Report

    Report Number
    2210968-2020-03546
    Event Type
    Injury
    Date Received
    April 28, 2020
    Report Date
    April 27, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 12/16/2020 ADDITIONAL INFORMATION: A2 DATE SENT TO THE FDA: 12/16/2020. CORRECTED INFORMATION: D6A. CORRECTED B5 NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR SURGERY ON (B)(6)2006 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 LEFT INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR SURGERY, DEBRIDEMENT OF PROPERITONEAL AND EXCISION OF FISTULOUS TO LEFT SCROTUM ON (B)(6) 2012. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468137 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention