BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVINE XENOSURE BIOLOGIC PATCH

    MDR report key: 7074824 · Received November 30, 2017

    Report

    Report Number
    MW5073662
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    November 13, 2017
    Report Date
    November 17, 2017
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED (B)(6) 2017 WITH FEVER, CHILLS, AND INCREASED SWELLING OF RIGHT SIDE OF NECK. PATIENT HAD A RIGHT ENDARTERECTOMY WITH PATCH ANGIOPLASTY ON (B)(6) 2017 AT (B)(6). PATIENT TAKEN TO THE OPERATING ROOM ON (B)(6) 2017 FOR I AND D FOR SURGICAL SITE. NECK ABSCESS FLUID HAS THUS FAR REVEALED GRAM POSITIVE COCCI. PATIENT QUALITIES FOR AN SSI. STREPTOCOCCUS AGALACTIAE. BOVINE XENOSURE BIOLOGIC PATCH LOT XBU2659 EXP DATE 04/28/2023 (NOTED ON SCANNED IMPLANT RECORD). 01/28/2023 (NOTED ON SURGINET OUTPUT RECORD). PREPARED WITH 0.9 PERCENT NSS LOT G130310 EXP AUG 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852428 BOVINE XENOSURE BIOLOGIC PATCH CAROTID PATCH DSY LEMAITRE VASCULAR, INC. XBU2659

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R