BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENMATRIX SURGICAL GRAFT

    MDR report key: 7457569 · Received April 24, 2018

    Report

    Report Number
    MW5076678
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    April 3, 2018
    Report Date
    April 23, 2018
    Manufacturer
    DAVOL, A BARD COMPANY
    Product Code
    FTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS IS A POTENTIAL PRODUCT PROBLEM. THE PATIENT IS A (B)(6) YEAR OLD FORMER (B)(6) PRETERM INFANT; NEONATAL COURSE COMPLICATED BY NECROTIZING ENTEROCOLITIS WITH BOWEL RESECTION. UNDERWENT MULTI-VISCERAL TRANSPLANT ON (B)(6) 2015. BECAUSE OF CHRONIC REJECTION UNDERWENT SECOND MULTI-VISCERAL TRANSPLANT ON (B)(6) 2017 WITH PLACEMENT OF XENMATRIX GRAFT TO REPAIR ABDOMINAL INCISION SITE. THE POST-OP COURSE WAS COMPLICATED BY INTERMITTENTLY POSITIVE BLOOD CULTURE: (B)(6) 2017 FOR MICROBACTERIUM ABSCESSUS. TREATED WITH 4-DRUG REGIMEN: AMIKACIN - S, IMIPENEM - I, LINEZOLID - I, AND AZITHROMYCIN - S FOR 8 WEEKS UNTIL (B)(6) 2018. BEGAN HAVING FEVER ON (B)(6) 2018 WITH INCREASING INFLAMMATORY MARKERS. THERE IS A BIOPSY OF AN INTRA-ABDOMINAL MASS ADJACENT TO XENMATRIX POSITIVE FOR ACID-FAST BACILLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295978 XENMATRIX SURGICAL GRAFT SURGICAL MESH FTM DAVOL, A BARD COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR