BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVINE XENOSURE BIOLOGIC PATCH

    MDR report key: 7071502 · Received November 30, 2017

    Report

    Report Number
    MW5073648
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    October 11, 2017
    Report Date
    November 17, 2017
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DXZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CEA ON (B)(6) 2017. PRESENTED TO ED ON (B)(6) 2017 C/O LUMP ON SIDE OF NECK AT SITE OF CEA, RED, WARM TO TOUCH, PAINFUL. ED DISCUSSED WITH ON CALL VASCULAR SURGEON; ORAL ABX PRESCRIBED AND PT SENT HOME WITH EXPECTATION TO F/U IN OFFICE. SEEN IN VASCULAR OFFICE ON (B)(6) 2017 WHERE SUPERFICIAL ABSCESS WAS OBSERVED, I&D PERFORMED. BOIL ON DISTAL INCISION ON DAY OF I&D, DESCRIBED AS "SMALL LOCALIZED ABSCESS BETWEEN THE INFERIOR ASPECT OF THE LEFT NECK INCISION AND THE DRAIN INCISION. SMALL 1.5 CM X 1.5 CM FLUID COLLECTION BETWEEN THE TWO INCISIONS. MILD ERYTHEMA. NO FEVER, CHILLS. NO FLUID COLLECTION ON CT. XENOSURE PATCH LOT XBU2460, EXP 01/28/2023, PREP FLUID 0.9% NSS LOT G130039. EXP: AUGUST 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852341 BOVINE XENOSURE BIOLOGIC PATCH CAROTID PATCH DXZ LEMAITRE VASCULAR, INC. XBU2460

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R