BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOVISC INJ 15MG/ML

    MDR report key: 7009668 · Received November 8, 2017

    Report

    Report Number
    MW5073179
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    November 3, 2017
    Report Date
    November 3, 2017
    Manufacturer
    UNK
    Product Code
    MOZ
    UDI-DI
    59676036001
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED THAT AFTER RECEIVING HER SECOND SET OF INJECTIONS FOR BILATERAL KNEES MONTHS AGO. SHE STARTED DEVELOPING ISSUES WITH HER MOUTH THAT WAS LATER DIAGNOSED AS PEMPHIGOID (MUCOUS MEMBRANE TYPE IN MOUTH). PATIENT STATED SHE FEELS AS THERE MAY HAVE BEEN SOME SORT OF ASSOCIATION BETWEEN THE TIMING OF THE ORTHOVISC INJECTIONS AND ONSET OF PEMPHIGOID ONSET. SHE IS NOW BEING TREATED WITH PREDNISONE AND CELLCEPT FOR THIS CONDITION AND WILL RECEIVE ANOTHER SET OF KNEE INJECTIONS THIS MONTH. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790666 ORTHOVISC INJ 15MG/ML ACID, HYALURONIC, INTRAARTICULAR MOZ UNK 59676036001

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR