BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 2090121 · Received May 5, 2011

    Report

    Report Number
    1213643-2011-00201
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    February 3, 2010
    Report Date
    April 11, 2011
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT BASED ON THE INFO CURRENTLY AVAILABLE. FURTHERMORE, NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. PT DECLINED TO PROVIDE ANY CONTACT INFO; THEREFORE, NO FOLLOW-UP CAN BE MADE. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR CURRENT KNOWLEDGE. A DHR REVIEW HAS BEEN CONDUCTED. ALL PAPERWORK APPEARED COMPLETED AND ACCURATE.

    Description of Event or Problem · 1

    PT REPORTED: (B)(6) 2009 - PT UNDERWENT INGUINAL HERNIA REPAIR PROCEDURE WITH KUGEL MESH IMPLANT. THE PT REPORTED HE EXPERIENCED PAIN AFTER THE SURGERY AND HAD ISSUES WITH A TESTICLE THAT HAD MIGRATED TO HIS ABDOMEN. ON (B)(6) 2010 - THE PT UNDERWENT PARTIAL EXPLANT PROCEDURE AND WAS IMPLANTED WITH ANOTHER BARD MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUSI1877

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention