BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 3111901 · Received May 14, 2013

    Report

    Report Number
    2210968-2013-05519
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    November 1, 2011
    Report Date
    April 17, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2011 AND MESH WAS USED. THE PATIENT REPORTED HAVING REALLY BAD PAIN DURING SEX. THE PATIENT IS NOT ABLE TO LAY ON HER STOMACH SINCE THE MESH WAS PUT IN BECAUSE, THE PAIN FEELS LIKE SHE IS BEING RIPPED OPEN. AT TIMES, THE PATIENT FEELS SHE NEEDS TO THROW UP. THE PATIENT HAS RECEIVED SHOTS IN THE STOMACH AROUND THAT AREA AND THE PATIENT IS BEING SENT TO PAIN MANAGEMENT. THE PATIENT RECEIVED A SECOND OPINION FROM A SURGEON AND PLANS TO HAVE THE MESH REMOVED SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212287 PHYSIOMESH MESH, SURGICAL FTL ETHICON, INC. NA DE8GWCA0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention