BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 3033398 · Received April 3, 2013

    Report

    Report Number
    2210968-2013-03406
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THAT A PATIENT UNDERWENT A LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2012 AND MESH WAS IMPLANTED. APPROXIMATELY, ONE YEAR LATER THE PATIENT EXPERIENCED A RECURRENT HERNIA THAT BULGED THROUGH THE MESH. THE PATIENT REQUIRED A RE-OPERATION TO REPAIR THE DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136123 PHYSIOMESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention