BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOVISC

    MDR report key: 4379860 · Received December 29, 2014

    Report

    Report Number
    MW5039881
    Event Type
    Injury
    Date Received
    December 29, 2014
    Date of Event
    September 12, 2014
    Report Date
    December 29, 2014
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ORTHOVISC WAS RECOMMENDED TO ME TO EASE THE KNEE PAIN RELATED TO OSTEOARTHRITIS. I RECEIVED 4 TOTAL INJECTIONS ADMINISTERED BY A PROFESSIONAL. WHEN ASKED HOW EFFECTIVE THE SHOTS HAD BEEN, MY COMMON REPLY WAS I HAD FELT LITTLE IMPROVEMENT. UPON 4TH VISIT TO DOCTOR, WHEN ASKED SAME, I SAID I HAD FELT NO IMPROVEMENT, AS MATTER OF FACT I REMARKED THAT MY CONDITION SEEMED WORSE. I HAD SO MUCH KNEE PAIN, I REQUESTED A MEDICATION TO RELIEVE THE PAIN. THE DOCTOR RECOMMENDED AN ADDITIONAL SHOT. MY CONDITION HAS WORSENED. I CANNOT GET UP WITH ASSISTANCE OR PUSHING MYSELF UP (FOR EXAMPLE) WITH SOME KIND OF ARM CHAIR, PUSHING MYSELF UP WITH MY HAND RESTED ON THE SEAT OF MY CHAIR AND USING TABLE EDGE WITH OTHER HAND FOR BOOST. FURTHER, I CANNOT SIT DOWN IN A CHAIR WITHOUT SOME PHYSICAL ASSISTANCE. I QUESTION IF ANYTHING I AM SUFFERING WILL BE RELIEVED OR IF MY PROBLEMS CAN BE SOLVED. I AM AFRAID OF BEING PERMANENTLY DISABLED. I BELIEVE SOMETHING WENT REALLY WRONG. I HAD TO PURCHASE A BOOSTER CHAIR (WITH ARMS) TO GET UP AND DOWN ON THE TOILET, I TAKE EXCEDRIN EXTRA STRENGTH AND IBUPROFEN FOR PAIN RELIEFS. THE DOCTOR ADMINISTERING THE ORTHOVISC WAS NEGLIGENT IN GETTING BACK TO ME TO GIVE ME SOMETHING FOR PAIN, IT TOOK SEVERAL CALLS TO RESOLVE THE PROBLEM. PLEASE RESPOND TO MY E-MAIL ASAP WITH ANY SUGGESTIONS YOU MIGHT HAVE. I DO HAVE ONE FURTHER COMMENT. MY HUSBAND HAS SEVERE COPD AND CANCER. I AM HIS CARE GIVER AND IT HAS BEEN DIFFICULT FOR ME AT TIMES. DATES OF USE: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854927 ORTHOVISC PER ACMINISTRATOR MOZ

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability