BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7536605 · Received May 23, 2018

    Report

    Report Number
    1213643-2018-01662
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    October 1, 2012
    Report Date
    December 12, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741016622
    PMA / PMN Number
    K922916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE BARD/DAVOL PERFIX PLUG DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. TO DATE NO MEDICAL RECORDS HAVE BEEN PROVIDED. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." MEDICAL RECORDS WERE NOT PROVIDED AND THE DESCRIPTION DOES NOT CLEARLY DEFINE WHAT "REMOVE IT" IS REFERRING TO (EXAMPLE POSSIBLE MESH EXPLANT, PARTIAL EXPLANT, OR REMOVAL/REPAIR OF THE HERNIA DEFECT ITSELF WITHOUT EXPLANT OF PREVIOUSLY PLACED MESH). AS SUCH AT THIS TIME, WE HAVE NOT IDENTIFIED THIS AS REPORTED DEVICE EXPLANT. IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, 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. 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) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112780, LOT NUMBER HUVB1384 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2012: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." AS ALLEGED, THE PATIENT HAS BEEN INJURED SEVERELY AND PERMANENTLY. AS ALLEGED, THE PATIENT SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE DEFECTIVE BARD/DAVOL PERFIX PLUG THAT WAS IMPLANTED IN HER BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379063 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUVB1384 00801741016622

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Disability| R