BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 9379122 · Received November 26, 2019

    Report

    Report Number
    1213643-2019-11528
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    March 13, 2011
    Report Date
    November 26, 2019
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016615
    PMA / PMN Number
    K922916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES SURGICAL INTERVENTION TO REMOVE THE INFECTED MESH AND HAD RESECTION OF THE SMALL BOWEL; ALSO THERE WAS EVIDENCE OF FISTULAS AND THE MESH WAS COMPLETELY REMOVED. AS ALLEGED THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. INFECTION AND FISTULA FORMATION ARE KNOWN RISKS OF SURGERY AND ARE LISTED IN THE INSTRUCTION-FOR-USE AS POSSIBLE COMPLICATIONS. DHR REVIEW PERFORMED IDENTIFIED THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATION WITH NO DISCREPANCIES. 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. NOT RETURNED.

    Description of Event or Problem · 1

    PER LEGAL COURT FILE NUMBER (B)(4). IT IS ALLEGED BY THE PATIENT'S ATTORNEY THAT ON (B)(6) 2005, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA. IT IS ALLEGED THAT A BARD/DAVOL PERFIX PLUG MESH, REFERENCE NUMBER 0112770 AND LOT NUMBER 43CPD138 WAS IMPLANTED TO THE PATIENT. IT WAS ALLEGED BY THE PATIENT¿S ATTORNEY THAT ON (B)(6) 2011, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE INFECTED MESH AND HAD RESECTION OF THE SMALL BOWEL. ALSO THERE WAS EVIDENCE OF FISTULAS AND THE MESH WAS COMPLETELY REMOVED. AS ALLEGED THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. AS REPORTED, PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER FROM CHRONIC PAIN, AS WELL AS PSYCHOLOGICAL STRESS AND DEPRESSION. AS REPORTED, THE PATIENT EXPERIENCED DISABILITY, HOSPITALIZATIONS, ADDITIONAL SURGERIES AND WILL LIKELY REQUIRE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173192 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43CPD138 00801741016615

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S