BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENMATRIX AB

    MDR report key: 8034996 · Received November 2, 2018

    Report

    Report Number
    1213643-2018-03830
    Event Type
    Injury
    Date Received
    November 2, 2018
    Date of Event
    October 20, 2016
    Report Date
    November 2, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    PIJ
    PMA / PMN Number
    K151177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PATIENT'S ATTORNEY ALLEGES UNSPECIFIED INJURIES; HOWEVER, NO DETAILS HAVE BEEN PROVIDED REGARDING THE NATURE OF THE INJURY AND FOR THE ADDITIONAL SURGERY FOR EXPLANT OF THE DEVICE. NO MEDICAL RECORDS HAVE BEEN PROVIDED . INFORMATION IS LIMITED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2015:THE PATIENT WAS DIAGNOSED WITH A VENTRAL HERNIA AND UNDERWENT VENTRAL HERNIA REPAIR WITH A BARD/DAVOL XENMATRIX AB SURGICAL GRAFT PRODUCT. IN THE MONTHS FOLLOWING THE (B)(6) 2016 EXPLANT OF THE BARD/DAVOL XENMATRIX AB SURGICAL GRAFT, THE PATIENT CONTINUED TO EXPERIENCE CHRONIC ABDOMINAL PAIN, AND FURTHER EXPERIENCES SEVERAL MEDICAL ISSUES IN WHICH THE PATIENT IS CURRENTLY SEEKING ADDITIONAL MEDICAL TREATMENTS FOR. AS A RESULT OF HAVING THE PRODUCT (BARD/DAVOL XENMATRIX AB SURGICAL GRAFT), THE PATIENT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING AND MENTAL ANGUISH, HAS SUSTAINED PERMANENT INJURY, HAS UNDERGONE MEDICAL TREATMENT AND/OR CORRECTIVE SURGERY HOSPITALIZATION AND WILL LIKELY UNDERGO FURTHER MEDICAL TREATMENT AND PROCEDURES. IT IS ALLEGED THAT THE BARD/DAVOL XENMATRIX AB SURGICAL GRAFT PRODUCT IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872923 XENMATRIX AB SURGICAL MESH PIJ DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S