BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH OVAL

    MDR report key: 3864194 · Received June 10, 2014

    Report

    Report Number
    2210968-2014-07363
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED AN INFECTION POST DEBRIDEMENT. THE INFECTION WAS RESOLVED (B)(6) 2013 WITH WOUND VAC AND CONTINUED MONITORING. THE PATIENT EXPERIENCED A RECURRENT HERNIA DIAGNOSED ON (B)(6) 2013 BUT HAS NOT UNDERGONE REOPERATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338488 PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK EH8CPRA0

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention