BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 8621660 · Received May 17, 2019

    Report

    Report Number
    1213643-2019-04035
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    June 16, 2009
    Report Date
    April 7, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSIONS CAN BE MADE REGARDING THE BARD/DAVOL PERFIX PLUG (DEVICE #1) USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID ALLEGE INJURIES; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THIS EMDR REPRESENTS THE BARD/DAVOL PERFIX PLUG (DEVICE #1). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL PERFIX PLUG (DEVICE #2). THE PATIENT'S ATTORNEY DID NOT MAKE ANY ALLEGATIONS REGARDING THE IMPLANTED BARD/DAVOL BARD MESH DEVICE. NOT RETURNED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #1) ON (B)(6) 2005. IT WAS ALLEGED THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #2) ON (B)(6) 2005. IT WAS ALLEGED THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD MESH ON (B)(6) 2009. IT IS ALLEGED BY PATIENT¿S ATTORNEY THAT ON (B)(6) 2009, PATIENT HAD UNSPECIFIED INJURIES. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414478 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability