BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPGENRA (EPTOTERMIN ALFA)

    MDR report key: 3810189 · Received April 25, 2014

    Report

    Report Number
    1224732-2014-00030
    Event Type
    Other
    Date Received
    April 25, 2014
    Report Date
    April 9, 2014
    Manufacturer
    OLYMPUS BIOTECH
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, OLYMPUS BIOTECH PHARMACOVIGILANCE RECEIVED A REPORT OF WOUND INFLAMMATION IN PATIENTS WHO RECEIVED OPGENRA FOR POSTEROLATERAL LUMBAR SPINAL FUSIONS. A PHYSICIAN REPORTED A 'HIGH DEGREE OF WOUND INFLAMMATION' WHEN OPGENRA WAS USED IN THE PLF PROCEDURES. THE PHYSICIAN REPORTED THAT HE COULD NOT ATTRIBUTE THE INFLAMMATION TO THE OPGENRA SPECIFICALLY, HOWEVER, HE DID STATE THAT THE WOUND INFLAMMATION WAS MILD IN NATURE AND DID NOT REQUIRE INTERVENTION. THE OLYMPUS BIOTECH MEDICAL REVIEWER ASSESSED THE EVENTS AS NON SERIOUS, EXPECTED AND POSSIBLY CAUSALLY RELATED TO THE OPGENRA. THE REPORT WAS RECEIVED AS PART OF A DEVELOPMENT OF VALUE MESSAGES FOR OPGENRA INTERVIEW CONDUCTED BY (B)(4) ON BEHALF OF OLYMPUS BIOTECH INTERNATIONAL. NO ADD'L INFO WAS RECEIVED WITH THE INITIAL REPORT. ADD'L INFO WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250648 OPGENRA (EPTOTERMIN ALFA) IMPLANT MQV OLYMPUS BIOTECH U NK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK