BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5073661

    MDR report key: 7074808 · Received November 30, 2017

    Report

    Report Number
    MW5073661
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    October 4, 2017
    Report Date
    November 17, 2017
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A RIGHT CAROTID ENDARTERECTOMY ON (B)(6) 2017. PATIENT SEEN AT ON (B)(6) 2017 C/O PURULENT DRAINAGE, SWELLING, AND PAIN FROM INCISION. PATIENT WAS MADE A DIRECT ADMIT AND TAKEN BACK TO THE OPERATING ROOM ON (B)(6) 2017 FOR WOUND IRRIGATION AND DRAINAGE OF A SUPERFICIAL ABSCESS OF THE RIGHT NECK WOUND. PATIENT QUALIFIES FOR A DEEP INCISIONAL SSI RIGHT ELECTIVE CEA WITH PATCH ANGIOPLASTY. TWO DAYS POST OPERATION RIGHT NECK PAIN, DISCOMFORT, SWELLING, REDNESS. SWELLING, DRAINAGE FROM INCISION, DIZZINESS, PAIN AT SITE; YELLOW DRAINAGE. XENOSURE PATCH LOT XBU2288, EXP 11/28/2022, PREP FLUID 0.9 PERCENT, NSS LOT G130039 PER INTRAOPERATIVE RECORD.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R