BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1150553 · Received September 4, 2008

    Report

    Report Number
    2210968-2008-00776
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    July 12, 2008
    Report Date
    August 1, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K031925
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT DEVELOPED A RASH / HIVES WITHIN 24 HOURS OF A LAPAROSCOPIC UMBILICAL HERNIA REPAIR. THE PT WAS TREATED WITH BENADRYL AND STEROIDS AND EXPERIENCED MILD RELIEF. THE PT WAS SUBSEQUENTLY PRESCRIBED PREDNISONE AND ANTIBIOTICS. THE REDNESS RESOLVED APPROX. THREE WEEKS FOLLOWING ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention