BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISEAL SKIN ADHESIVE

    MDR report key: 7813113 · Received August 23, 2018

    Report

    Report Number
    MW5079372
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    June 26, 2018
    Report Date
    August 22, 2018
    Manufacturer
    ADHEZION BIOMEDICAL, LLC
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD A SPINAL CORD STIMULATOR PLACEMENT AND T10-T11 THORACIC LAMINECTOMY. THE PT RETURNED TO THE SURGEON'S OFFICE FOR POST-OP VISIT AND HAD VISIBLE RASH-LIKE / RED IRRITATION AROUND THE INCISION SITE. MULTIPLE PTS OVER A 6 MONTH TIME PERIOD WITH SIMILAR ISSUES. (B)(4). THERAPY START DATE: (B)(6) 2018; THERAPY END DATE: (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652587 SURGISEAL SKIN ADHESIVE TISSUE ADHESIVE TOPICAL APPROXIMATION OF SKIN MPN ADHEZION BIOMEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other