BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODIFIED KUGEL PATCH

    MDR report key: 3204345 · Received June 27, 2013

    Report

    Report Number
    1213643-2013-00272
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    March 9, 2011
    Report Date
    September 11, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K96314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON REVIEW OF THE MEDICAL RECORDS THE PT DEVELOPED A HERNIA AFTER LIFTING SOMETHING AT WORK, AND UNDERWENT REPAIR WITH A MODIFIED KUGEL PATCH. APPROXIMATELY SIX MONTHS POST IMPLANT THE PT PRESENTED TO THE ER WITH SEVERE PAIN IN THE RIGHT GROIN. AN MRI SHOWED NO RECURRENCE AND HER MD NOTED A POSSIBLE CAUSE FOR THE PAIN WAS SCAR TISSUE. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT ADDITIONALLY THE MESH REMAINS IMPLANTED. THIS MDR INCLUDES ALL PT, EVENT, AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/OR EVALUATION INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. PMA/510 (K): K021736.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF THE PT'S MEDICAL RECORDS: (B)(6) 2010 - PATIENT WAS IMPLANTED WITH A BARD MODIFIED KUGEL PATCH FOR RIGHT INGUINAL HERNIA REPAIR. ON (B)(6) 2011 - PT PRESENTED TO THE ER WITH SEVERE PAIN IN THE RIGHT GROIN. A MRI WAS DONE. NO RECURRENT HERNIA WAS SEEN. SCAR TISSUE WAS SEEN, WHICH THE MD FELT WAS CAUSING THE PTS PAIN. THE FOLLOWING IS ALLEGED BY THE PT'S ATTORNEY, DISABILITY, PAIN, ADDITIONAL SURGERY, FOLLOWING IMPLANT OF THE DEVICE. ALLEGES MRI SHOWED MESH HAD IMPINGED INTO THE PT'S BLADDER. PT ADVISED AGAINST SURGERY TO EXPLANT DUE TO THE RISKY NATURE OF THE EXPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291817 MODIFIED KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43EQD162

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability