BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2972853 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01502
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A HERNIA REPAIR PROCEDURE IN 2011 AND MESH WAS IMPLANTED. SHE EXPERIENCED PAIN. THE PATIENT STATES THAT SHE DEVELOPED A RECURRENT HERNIA WITH ADHESIONS TO THE BOWEL AND REQUIRED ADDITIONAL SURGERY TO REPAIR THE DEFECT. THE SYMTOMS SUBSIDED AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77142 PHYSIOMESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention