BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAMESH IP

    MDR report key: 17085448 · Received June 8, 2023

    Report

    Report Number
    1213643-2023-092288
    Event Type
    Injury
    Date Received
    June 8, 2023
    Report Date
    June 8, 2023
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES "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"; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THIS EMDR REPRESENTS THE BARD/DAVOL SEPRAMESH IP (DEVICE #8). ADDITIONAL EMDR¿S WERE SUBMITTED TO REPRESENT THE BARD/DAVOL MESH ¿ DART (DEVICE #1), BARD FLAT MESH(DEVICE #2), SEPRAMESH IP (DEVICE #3), SEPRAMESH IP (DEVICE #4), MESH ¿ VENTRALEX (DEVICE #5), BARD FLAT MESH(DEVICE #6), MESH ¿ VENTRALEX (DEVICE #7), VENTRIO ST (DEVICE #9), VENTRALIGHT ST MESH (DEVICE #10) AND VENTRALIGHT ST MESH (DEVICE #11). SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. H3 OTHER TEXT : NOT RETURNED

    Description of Event or Problem · 0

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH DART ON (B)96)2009, BARD MESH (BARD FLAT MESH) (X2) ON (B)(6)2009 AND (B)(6)2011, BARD/DAVOL SEPRAMESH COMPOSITE IP (X3) ON (B)(6)2010 AND (B)(6)2012, VENTRALEX (X2) ON (B)(6)2011 AND (B)(6)2012, VENTRIO ST ON (B)(6)2013, VENTRALIGHT ST (X2) ON (B)(6)2020, PHASIX MESH (X2) ON (B)(6)2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH DART, BARD MESH (BARD FLAT MESH) (X2), SEPRAMESH COMPOSITE IP(X3), VENTRALEX (X2), VENTRIO ST AND VENTRALIGHT ST (X2). 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." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068071 SEPRAMESH IP SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability