BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MUTLI-LAYER LAMINATE MESH

    MDR report key: 1233943 · Received November 14, 2008

    Report

    Report Number
    2210968-2008-01120
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 11/14/2008. PAIN OCCURRED. CONCLUSION: A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. 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 THE PATIENT UNDERWENT AN OPEN, LEFT FLANK HERNIA REPAIR PROCEDURE IN 2008. DURING THIS PROCEDURE, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND A SURGICAL MESH WAS USED. THE PROCEDURE WENT WELL. POSTOPERATIVELY, THE PATIENT REPORTED HAVING INTENSE PAIN AND POSSIBLY NERVE DAMAGE. THE PATIENT WAS SEEN BY THE OPERATING SURGEON ON THE FOLLOWING DATES COMPLAINING OF PAIN WITH THE FOLLOWING INTERVENTIONS: TWO MONTHS LATER, (TOLD TO TAKE IBUPROFEN 400 MG, THREE TIMES A DAY FOR 7 DAYS), IN THE SAME MONTH, (GIVEN A 5CC 1% LIDOCAIN WITH .25% MARCAIN INJECTION JUST BELOW THE FASCIA), THE FOLLOWING MONTH. AT THE LAST VISIT IN 2008, THE PATIENT WAS REFERRED TO A PAIN CLINIC. NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MUTLI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA ZBG149

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention