BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7289991 · Received February 22, 2018

    Report

    Report Number
    1213643-2018-00354
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    July 26, 2016
    Report Date
    November 13, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016653
    PMA / PMN Number
    K922916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    ADDENDUM TO PREVIOUS INFORMATION. THIS SUPPLEMENTAL EMDR IS BEING SENT TO PROVIDE ADDITIONAL PATIENT AND MEDICAL INFORMATION. THE ADDITIONAL MEDICAL RECORDS PROVIDED WERE LIMITED TO THE PATIENT'S IMPLANT OPERATIVE REPORT FOR THE PERFIX PLUG ONLY. WITH THE CURRENT INFORMATION AVAILABLE, THE CONCLUSION FOR THIS FILE REMAINS INCONCLUSIVE.

    Description of Event or Problem · 0

    AS ORIGINALLY REPORTED IN 02/2018: (B)(6) 2016: THE PATIENT UNDERWENT A REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL PERFIX HERNIA PLUG, REF 0112950, LOT HUZD0858 AS POSITIVELY IDENTIFIED ON THE OPERATIVE REPORT, WAS IMPLANTED INTO THE PATIENT. (B)(6) 2016: THE PATIENT UNDERWENT SUBSEQUENT SURGERY TO EXPLORE THE LEFT INGUINAL REGION AND MESH REMOVAL. AS REPORTED, THE MESH WAS REMOVED DUE TO EXTREME PAIN AND DISCOMFORT. AS ALLEGED, THE PATIENT HAS EXPERIENCED AND CONTINUES TO EXPERIENCE ABDOMINAL DISCOMFORT AND "ALL RELATED SEQUELAE." AS ALLEGED, THE PATIENT HAS SUFFERED SERIOUS BODILY INJURIES THAT HAVE RESULTED IN PAIN AND SUFFERING, DISABILITY, MEDICAL AND NURSING CARE AND TREATMENT, AGGRAVATION OF A PREEXISTING CONDITION, AND INTEREST ON THE FOREGOING INJURIES DUE TO THE ALLEGED DEFECTIVE HERNIA MESH PRODUCT. ADDENDUM BASED ON ADDITIONAL MEDICAL RECORDS REVIEWED: (B)(6) 2016 - THE PATIENT WAS DIAGNOSED WITH A LEFT INGUINAL HERNIA AND UNDERWENT REPAIR WITH IMPLANT OF A PERFIX PLUG MESH. PER THE IMPLANT OPERATIVE REPORT DETAILS, "A LIPOMATOUS HERNIA EMANATES THROUGH THE INTERNAL RING WAS IDENTIFIED. AT THIS POINT, A SMALL PLUG WAS SOAKED IN ANTIBIOTICS, WAS PLACED INTO THE INTERNAL RING AND SECURED TO THE CONJOINED TENDON AND TO THE UNDERSURFACE OF THE INGUINAL LIGAMENT. AT THIS POINT, THE AREA WAS IRRIGATED OUT AND THEN THE MARLEX PATCH WAS SECURED OVERLYING THE FLOOR TO THE PUBIC TUBERCLE TO THE UNDERSURFACE OF THE INGUINAL LIGAMENT AND TO THE CONJOINED TENDON."

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT SUBSEQUENT SURGERY "TO EXPLORE THE LEFT INGUINAL REGION AND MESH REMOVAL", HOWEVER, NO SPECIFIC DEVICE FAILURE IS PROVIDED AND MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME. 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) 2016: THE PATIENT UNDERWENT A REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL PERFIX HERNIA PLUG, REF 0112950, LOT HUZD0858 AS POSITIVELY IDENTIFIED ON THE OPERATIVE REPORT, WAS IMPLANTED INTO THE PATIENT. ON (B)(6) 2016: THE PATIENT UNDERWENT SUBSEQUENT SURGERY TO EXPLORE THE LEFT INGUINAL REGION AND MESH REMOVAL. AS REPORTED, THE MESH WAS REMOVED DUE TO EXTREME PAIN AND DISCOMFORT. AS ALLEGED, THE PATIENT HAS EXPERIENCED AND CONTINUES TO EXPERIENCE ABDOMINAL DISCOMFORT AND "ALL RELATED SEQUELAE." AS ALLEGED, THE PATIENT HAS SUFFERED SERIOUS BODILY INJURIES THAT HAVE RESULTED IN PAIN AND SUFFERING, DISABILITY, MEDICAL AND NURSING CARE AND TREATMENT, AGGRAVATION OF A PREEXISTING CONDITION, AND INTEREST ON THE FOREGOING INJURIES DUE TO THE ALLEGED DEFECTIVE HERNIA MESH PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133641 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUZD0858 00801741016653

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention| S