BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH

    MDR report key: 1060384 · Received June 12, 2008

    Report

    Report Number
    2210968-2008-00435
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS EVENT WAS REPORTED BY THE FACILITY AS NOT BEING PROD RELATED, HOWEVER, THE EVENT WAS PROCEDURE RELATED. 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

    IT WAS REPORTED THAT THE PT UNDERWENT A RIGHT AND LEFT INGUINAL HERNIA REPAIR PROCEDURE IN 2008. DURING THIS PROCEDURE, THE SURGICAL MESH WAS USED ON THE RIGHT SIDE AND BARD MESH WAS USED ON THE LEFT SIDE. THE PT HAS SOME URINARY RETENTION POST-OPERATIVELY AND A FOLEY CATHETER WAS PLACED. ON POSTOPERATIVE DAY ONE, THE FOLEY CATHETER WAS REMOVED, THE PT WAS ABLE TO VOID AND WAS DISCHARGED. THEN, AT ABOUT 3 WEEKS POST-OP, THE PT DEVELOPED DYSURIA. AS A RESULT, A UA C&S WAS SENT IN THE SAME DAY. THE URINALYSIS RESULTS SHOWED AN INFECTION. IN THE NEXT DAY, THE PT WAS STARTED ON LEVAQUIN 500 MG BY MOUTH FOR 5 DAYS. THIS EVENT HAS BEEN LISTED AS MILD IN INTENSITY. THE DR HAS INDICATED THAT THE EVENT WAS NOT PROD RELATED BUT WAS POSSIBLY PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPRO MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA ZL9GLRB0

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention BARD MESH-04/18/2008