BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7492474 · Received May 7, 2018

    Report

    Report Number
    1213643-2018-01362
    Event Type
    Injury
    Date Received
    May 7, 2018
    Report Date
    May 7, 2018
    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 Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO CONNECTION THAT CAN BE MADE AT THIS TIME BETWEEN THE REPORTED UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND ANY PROBLEM WITH THE BARD/DAVOL PERFIX PLUG (DEVICE #4) USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT ADVERSE EVENT, AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THIS EMDR REPRESENTS THE BARD/DAVOL PERFIX PLUG (DEVICE #4). ADDITIONAL EMDR WERE SUBMITTED TO REPRESENT THE BARD/DAVOL PERFIX PLUG (DEVICE #1, DEVICE #2, AND DEVICE #3). THE PATIENT'S ATTORNEY DID NOT MAKE ANY ALLEGATIONS REGARDING THE IMPLANTED BARD/DAVOL VENTRIO ST DEVICE. 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) 2015: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST AND FOUR (4) BARD/DAVOL PERFIX PLUGS, LOT NUMBER HUYF1810, REFERENCE NUMBER 0112770 (DEVICE #1); LOT NUMBER HUYF1810, REFERENCE NUMBER 0112770 (DEVICE #2); LOT NUMBER HUZA0039, REFERENCE NUMBER 0112770 (DEVICE #3) AND LOT NUMBER HUYH1728, REFERENCE NUMBER 0112770 (DEVICE #4). AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL PERFIX PLUGS (DEVICE #1, DEVICE #2, DEVICE #3, AND DEVICE #4). AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS AGAINST THE BARD/DAVOL PERFIX PLUGS (DEVICE #1, DEVICE #2, DEVICE#3, AND DEVICE #4) 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
    333824 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUYH1728 00801741016615

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability