BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7739129 · Received August 1, 2018

    Report

    Report Number
    1213643-2018-02551
    Event Type
    Injury
    Date Received
    August 1, 2018
    Date of Event
    July 13, 2015
    Report Date
    November 6, 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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDENDUM TO THE PREVIOUS REPORT. THIS SUPPLEMENTAL EMDR IS BEING SENT DUE TO ADDITIONAL MEDICAL RECORDS RECEIVED. IT WAS ORIGINALLY ALLEGED THAT THE PATIENT UNDERWENT EXPLANT OF THE PERFIX PLUG IN THE (B)(6) 2015 PROCEDURE. BASED ON MEDICAL RECORDS PROVIDED, THERE IS NO MENTION OR INDICATION OF THE PERFIX PLUG BEING REMOVED DURING THIS PROCEDURE. NO CONCLUSIONS CAN BE MADE AT THIS TIME REGARDING THE CAUSE OF THE PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    AS WAS ORIGINALLY REPORTED IN 08/2018: THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2014: THE PATIENT UNDERWENT A LEFT INGUINAL HERNIA REPAIR PROCEDURE TO INTRODUCE A BARD/DAVOL PERFIX PLUG (DEVICE #1) LOT # HUXA0687, REFERENCE NUMBER: 0112780 TO PATIENT'S PERITONEAL CAVITY TO REINFORCE TISSUE AFFECTED BY THE HERNIA. ON (B)(6) 2015: THE PATIENT UNDERWENT A SUBSEQUENT SURGERY TO REMOVE THE BARD/DAVOL PERFIX PLUG (DEVICE #1) DUE TO A RECURRENT LEFT INGUINAL HERNIA. DURING THIS SURGERY, THE PATIENT'S SURGEON IMPLANTED AN UNSPECIFIED BARD/DAVOL 3DMAX INTO THE PATIENT'S BODY. THE PATIENT'S ATTORNEY ALLEGED AS A DIRECT AND PROXIMATE RESULT OF THE BARD/DAVOL PERFIX PLUG (DEVICE #1) THE PATIENT EXPERIENCED HERNIA RECURRENCE. IN ADDITION, THE PATIENT HAS EXPERIENCED SWELLING AND INTESTINAL PROTRUSION ON THE SIDE OF HIS HERNIA REPAIR SURGERIES RESULTING IN EXCRUCIATING PAIN. THE PATIENT HAS SUFFERED SEVERE AND POSSIBLY PERMANENT INJURIES. THE PATIENT HAS SUFFERED SERIOUS BODILY INJURIES THAT HAVE RESULTED IN PAIN AND SUFFERING, DISABILITY, MEDICAL AND NURSING CARE AND TREATMENT. ADDENDUM BASED ON MEDICAL RECORDS PROVIDED AND THE ATTORNEY'S LEGAL CLAIM: (B)(6) 2014: THE PATIENT UNDERWENT A LEFT INGUINAL HERNIA REPAIR PROCEDURE TO INTRODUCE A PERFIX PLUG TO PATIENT'S PERITONEAL CAVITY TO REINFORCE TISSUE AFFECTED BY THE HERNIA. ON (B)(6) 2015 - THE PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND UNDERWENT A LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR WITH IMPLANT OF A 3DMAX MESH. BASED ON OPERATIVE DICTATION NOTES "A 3DMAX LARGE MESH WAS PLACED INTO THE SPACE AND COMPLETELY COVER THE DIRECT, INDIRECT AND FEMORAL SPACES. THE PLUG WAS ANTERIOR TO THE THIS NEW MESH AND WAS INTIMATELY INVOLVED WITH THE INFERIOR EPIGASTRIC VESSELS. A SORBAFIX TACKER WAS THEN USED TO TACK THE MESH MOST INFERIOR BORDER INTO COOPERS LIGAMENT AS WELL AS THE PUBIC TUBERCLE." BASED ON THE MEDICAL RECORDS PROVIDED THERE WAS NO MENTION OR INDICATION OF THE PREVIOUS PERFIX PLUG BEING REMOVED.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE BARD/DAVOL PERFIX PLUG (DEVICE #1) DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE. THE INFORMATION PROVIDED ALLEGES MEDICAL INTERVENTION TO EXPLANT THE DEVICE DUE TO RECURRENCE OF THE HERNIA, SWELLING, PERMANENT INJURIES AND DISABILITY. NO MEDICAL RECORDS HAVE BEEN PROVIDED; HOWEVER, RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. THIS EMDR REPRESENTS THE BARD/DAVOL PERFIX PLUG (DEVICE #1). THE PATIENT'S ATTORNEY DID NOT MAKE ANY ALLEGATIONS REGARDING THE IMPLANTED BARD/DAVOL 3DMAX DEVICE. 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) 2014: THE PATIENT UNDERWENT A LEFT INGUINAL HERNIA REPAIR PROCEDURE TO INTRODUCE A BARD/DAVOL PERFIX PLUG (DEVICE #1) LOT # HUXA0687, REFERENCE NUMBER: 0112780 TO PATIENT'S PERITONEAL CAVITY TO REINFORCE TISSUE AFFECTED BY THE HERNIA. ON (B)(6) 2015: THE PATIENT UNDERWENT A SUBSEQUENT SURGERY TO REMOVE THE BARD/DAVOL PERFIX PLUG (DEVICE #1) DUE TO A RECURRENT LEFT INGUINAL HERNIA. DURING THIS SURGERY, THE PATIENT'S SURGEON IMPLANTED AN UNSPECIFIED BARD/DAVOL 3DMAX INTO THE PATIENT'S BODY. THE PATIENT'S ATTORNEY ALLEGED AS A DIRECT AND PROXIMATE RESULT OF THE BARD/DAVOL PERFIX PLUG (DEVICE #1) THE PATIENT EXPERIENCED HERNIA RECURRENCE. IN ADDITION, THE PATIENT HAS EXPERIENCED SWELLING AND INTESTINAL PROTRUSION ON THE SIDE OF HIS HERNIA REPAIR SURGERIES RESULTING IN EXCRUCIATING PAIN. THE PATIENT HAS SUFFERED SEVERE AND POSSIBLY PERMANENT INJURIES. THE PATIENT HAS SUFFERED SERIOUS BODILY INJURIES THAT HAVE RESULTED IN PAIN AND SUFFERING, DISABILITY, MEDICAL AND NURSING CARE AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580892 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUXA0687 00801741016622

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention| S