BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 3911554 · Received June 26, 2014

    Report

    Report Number
    1213643-2014-00203
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    April 18, 2012
    Report Date
    June 6, 2014
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENTLY AVAILABLE INFORMATION WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. AS REPORTED THAT PATIENT EXPERIENCED POST-OPERATIVE PAIN AND WAS TREATED WITH PAIN MEDICATION. PATIENT WAS LATER DIAGNOSED WITH C-DIFFICILE, WHICH CAN BE CONTRACTED A NUMBER OF DIFFERENT WAYS. IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR HEMATOMA AND INFLAMMATION BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE REACTIONS LISTED IN THE IFU. A MANUFACTURING REVIEW THAT INCLUDED REVIEW OF STERILITY RECORDS WAS PERFORMED AND DID NOT FIND EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, THE MESH REMAINS IMPLANTED. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL VIA MAUDE EVENT REPORT ((B)(4)) AND INFORMATION PROVIDED BY CONTACT. IT WAS ALLEGED THAT ON (B)(6) 2012 THE PATIENT UNDERWENT REPAIR OF A VERY LARGE COMBINED DIRECT AND INDIRECT DEFECT WITH THE IMPLANT OF A PERFIX PLUG. IT WAS REPORTED THAT HE HAD SIGNIFICANT POSTOPERATIVE PAIN WHICH WAS TREATED WITH PAIN MEDICATIONS (NEURONTIN, ROUBAIX, PERCOCET) AND RECHECKED IN 8 WEEKS. REPORTED THIS RESULTED IN A REDUCTION IN THE PAIN LEVEL. REPORTEDLY, A CT SCAN SHOWED INFLAMMATORY CHANGE IN THE SUBCUTANEOUS FAT ANTERIOR TO THE RIGHT INGUINAL AREA AND SOME SOFT TISSUE DENSITY ON THE INTRAABDOMINAL ASPECT OF THE RIGHT INGUINAL CANAL. SAID LIKELY HEMATOMA OR INFLAMMATORY REACTION TO THE MESENTERY RELATED TO HERNIA REPAIR; HOWEVER, THERE WAS NO DEFINITE EVIDENCE TO SUGGEST ABCESS. CONTACT REPORTED THAT ONE MORNING, HER HUSBAND WAS NOT BREATHING AND WAS UNRESPONSIVE. HIS FAMILY WAS TOLD THAT HE MAY HAVE SUFFERED A STROKE. A CT SCAN WAS PERFORMED AND REVEALED THERE WAS NO BLOOD CLOT; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS SEPTIC, HAD PNEUMONIA, ACUTE RESPIRATORY FAILURE, RENAL FAILURE AND HE WAS TAKEN TO THE ICU. THE CONTACT REPORTS THAT AFTER MULTIPLE TESTS, SHE WAS TOLD BY ONE OF THE DOCTORS THAT THE PATIENT HAD C-DIFFICILE, WHICH WAS THE ROOT CAUSE. PATIENT STILL HAS RESIDUAL PAIN AND OTHER SYMPTOMS SUCH AS CONFUSION, DIFFICULTY TALKING AND PHYSICAL DISABILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373022 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUWB1049

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R