BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7287300 · Received February 21, 2018

    Report

    Report Number
    1213643-2018-00341
    Event Type
    Injury
    Date Received
    February 21, 2018
    Report Date
    September 24, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031496
    PMA / PMN Number
    K101928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS AN ADDENDUM TO THE INITIAL MDR TO DOCUMENT ADDITIONAL INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY. THE ADDITIONAL INFORMATION RECEIVED WAS LIMITED TO THE ADDITIONAL ATTORNEY'S ALLEGATION REGARDING THE PATIENT OUTCOME AND TREATMENT, HOWEVER, NO MEDICAL RECORDS HAVE BEEN PROVIDED. 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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ORIGINALLY ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2015: THE PATIENT UNDERWENT IMPLANT OF THE BARD/DAVOL VENTRALEX ST MESH, 5950009. NI/NI/NI: ATTORNEY ALLEGES THE MESH WAS LATER EXPLANTED DUE TO INJURIES IT WAS CAUSING THE PATIENT. ATTORNEY ALSO ALLEGES THE MESH WAS DEFECTIVE. ADDENDUM BASED ON ADDITIONAL INFORMATION PROVIDED BY PATIENTS ATTORNEY: (B)(6) 2015, THE PATIENT UNDERWENT SURGERY THAT REQUIRED IMPLANTATION OF A BARD/DAVOL VENTRALEX ST . IT IS ALLEGED THAT THE BARD/DAVOL VENTRALEX ST IS DEFECTIVE. THE PATIENT WAS CAUSED TO SUFFER SERIOUS AND SEVERE PERSONAL INJURIES TO VARIOUS PARTS OF THE PATIENT'S BODY AND LIMBS, RENDERING THE PATIENT SICK, SORE, LAME, AND DISABLED; CAUSING HER TO BECOME CONFINED TO BED, HOSPITAL AND HOME FOR A PERIOD OF TIME; REQUIRING HER TO UNDERGO REHABILITATIVE TREATMENTS.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT "DUE TO THE DEFECTIVE NATURE OF THE MESH, IT WAS REQUIRED TO BE SURGICALLY REMOVED", HOWEVER, THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR REASON FOR EXPLANT. NO MEDICAL RECORDS HAVE BEEN PROVIDED. 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. 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 IMPLANT OF THE BARD/DAVOL VENTRALEX ST MESH, 5950009. NI/NI/NI: ATTORNEY ALLEGES THE MESH WAS LATER EXPLANTED DUE TO INJURIES IT WAS CAUSING THE PATIENT. ATTORNEY ALSO ALLEGES THE MESH WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129634 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI 00801741031496

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R