BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 2892263 · Received December 17, 2012

    Report

    Report Number
    1213643-2012-00877
    Event Type
    Injury
    Date Received
    December 17, 2012
    Report Date
    November 29, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, IT APPEARS THAT THE MESH REMAINS IMPLANTED. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN. IF ADDITIONAL EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED. SEE MDR 1213643-2012-00876 FOR INFO RELATED TO THE PERFIX PLUG IMPLANTED ON THE PT'S RIGHT SIDE ON (B)(6) 2004. SEE MDR 1213643-2012-00878 FOR INFO RELATED TO THE VENTRALEX MESH IMPLANTED ON (B)(6) 2006.

    Description of Event or Problem · 1

    THE FOLLOWING HAS BEEN REPORTED TO DAVOL BY THE PT'S WIFE: ON (B)(6) 2004, THE PT WAS IMPLANTED WITH PERFIX PLUG FOR REPAIR OF A RIGHT INGUINAL HERNIA. THE PT WAS ALSO IMPLANTED WITH A PERFIX PLUG IN THE LEFT INGUINAL AREA. THE PT EXPERIENCED PERSISTENT PAIN IN BOTH SIDES FOLLOWING IMPLANT. THE RIGHT SIDED PAIN WAS GREATER THAN THE LEFT SIDE. ON (B)(6) 2006, THE PT UNDERWENT EXPLANT OF THE PERFIX PLUG ON THE RIGHT SIDE. THE MESH WAS NOTED TO BE "BUNCHED UP". A VENTRALEX MESH WAS PLACED AT THIS TIME IN THE RIGHT INGUINAL AREA. THE PT CONTINUES WITH BILATERAL INGUINAL PAIN THAT AFFECTS HIS DAILY LIVING. THE PT CAN NOT DO SEVERAL TASKS THAT HE COULD ONCE DO. HE HAS TO TAKE MEDICATION DAILY FOR THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43IND117

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability