BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 1103085 · Received August 8, 2008

    Report

    Report Number
    1213643-2008-00392
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    October 18, 2001
    Report Date
    July 11, 2008
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVAL OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2001- THE PT UNDERWENT A RIGHT INGUINAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF A PERFIX PLUG. ON THE EVENT DATE- THE PT REPORTS SHARP PAINS ACCOMPANIED BY ACHING, THROBBING SENSATIONS COMING FROM THE IMPLANT SITE. THIS PAIN AFFECTS HIS ABILITY TO WALK EASILY AND IS MADE WORSE WHEN THERE IS INCLEMENT WEATHER. THE PT REPORTS MEDICAL CONSULTATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43LJD143

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention