BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 2770819 · Received October 3, 2012

    Report

    Report Number
    2210968-2012-06018
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 11, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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 BY THE PATIENT THAT SHE UNDERWENT A VENTRAL HERNIA REPAIR IN (B)(6) 2008 AND MESH WAS USED. SHE REPORTS THAT SINCE HER SURGERY, SHE HAS HAD INTERMITTENT ABDOMINAL PAIN. SHE REPORTS THAT SHE IS UNABLE TO EXERCISE AND THAT HER STOMACH NOW "STICKS TO HER STOMACH". SHE REPORTS THAT SHE HAS HAD A HOSPITAL ADMISSION FOR ABDOMINAL PAIN THAT WAS RELATED TO HER DIVERTICULITIS PER HER PHYSICIAN. THE SURGEON OPINES THAT HER ABDOMINAL PAIN COULD BE RELATED TO THE MESH OR DIVERTICULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other