BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3893897 · Received June 25, 2014

    Report

    Report Number
    2210968-2014-08179
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT MW5035855.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2005 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED HERNIA RECURRENCE AND UNDERWENT ANOTHER HERNIA REPAIR PROCEDURE AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCES SPORADIC PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371793 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK AGB222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention