BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVINE XENOSURE BIOLOGIC PATCH

    MDR report key: 7071503 · Received November 30, 2017

    Report

    Report Number
    MW5073649
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    October 15, 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 ADMITTED ON (B)(6) 2017 WITH SWELLING, REDNESS, AND PAIN OVER LEFT NECK. ON (B)(6) 2017, PT HAD A LEFT CAROTID ENDARTERECTOMY WITH PATCH ANGIOPLASTY. ON (B)(6) 2017, TO OPERATING ROOM FOR I&D OF LEFT NECK ABSCESS WITH SIGNIFICANT PUS DOWN TO THE CAROTID SHEATH. PT QUALIFIES FOR SSI. NINE DAYS POST OPERATION, DISCOMFORT, DENIES FEVERS, CHILLS, NO DRAINAGE. INFECTION EXTENDED DEEP INTO THE CAROTID SHEATH AREA. CULTURED (B)(6), SEEP INCISION SURGICAL SITE INFECTION. BOVINE XENOSURE BIOLOGIC PATCH LOT XBU2460 EXP DATE: 01/28/2013 (NOTED ON SCANNED IMPLANT RECORD) (B)(6) 2023 - NOTED ON SURGINET OUTPUT RECORD. PREPARED WITH 0.9% NSS LOT G130310.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852376 BOVINE XENOSURE BIOLOGIC PATCH CAROTID PATCH DXZ LEMAITRE VASCULAR, INC. E 0.8P8 XBU2460

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R