BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7365011 · Received March 23, 2018

    Report

    Report Number
    1213643-2018-00737
    Event Type
    Injury
    Date Received
    March 23, 2018
    Date of Event
    February 21, 2017
    Report Date
    March 23, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016622
    PMA / PMN Number
    K922916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT "UNDERWENT REMOVAL OF THE FAILED PERFIX PLUG". AS REPORTED, THE DOCTOR NOTED "THE MESH CIRCUMFERENTIALLY WRAPPED AROUND THE CORD STRUCTURES"; HOWEVER, NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2013: THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112780, LOT NUMBER HUXE0445 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2017: THE PATIENT UNDERWENT REMOVAL OF THE FAILED PERFIX PLUG. AS REPORTED, UPON VISUALIZING THE FAILED PERFIX PLUG, THE SURGEON NOTED "THE MESH CIRCUMFERENTIALLY WRAPPED AROUND THE CORD STRUCTURES. I CAREFULLY DISSECTED THE MESH OFF THE CORD STRUCTURES AND RELEASE THE CIRCUMFERENTIAL WRAP. I THEN STARTED DISSECTING OUT THE MESH. THE PART OF THE MESH THAT IS SITTING WITHIN THE INGUINAL CANAL WAS CAREFULLY DISSECTED OFF AND REMOVED. THERE WAS SOME FLUID IN THE AREA OF THE MESH...I ELEVATED AND REMOVED AS MUCH OF THE MESH AS POSSIBLE FROM WITHIN THE INGUINAL CANAL ITSELF. AGAIN, THE MESH WAS SITTING AROUND THE INTERNAL RING. THE FLOOR OF THE INGUINAL CANAL APPEARS TO BE INTACT. UPON COMPLETION OF THIS PART OF THE DISSECTION, MOST OF THE MESH PATCH WAS REMOVED. SMALL PIECES WERE STILL INGROWN IN CERTAIN LOCATIONS. IT COULD NOT BE FULLY REMOVED. THE REST OF THE MESH AT THIS POINT [WAS] FULLY GONE. I PALPATED THE INTERNAL RING. IT WAS WIDELY OPEN, BUT WHAT I FEEL IN THE PALPATE IS POSSIBLY THERE IS A MESH PLUG THAT IS STILL SITTING WITHIN THE PERITONEAL CAVITY. I WAS ABLE TO PALPATE THE PLUG, BUT I COULD NOT GET TO. IT IS SOMEWHAT MIGRATED MORE SUPERIORLY AWAY FROM THE INTERNAL RING. WITH ONE FINGER, I WAS ABLE TO PALPATE THOUGH THE INTERNAL RING AND FOUND THE HARD AREA OF WHAT I BELIEVE IS THE PLUG SITTING UP HIGH. BECAUSE I COULD NOT GET TO THE PLUG, I LEFT IT BEHIND..." AS ALLEGED, THE PATIENT CONTINUES TO SUFFER SEVERE PAIN ASSOCIATED WITH THE FAILED PERFIX PLUG AND HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209034 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUXE0445 00801741016622

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S