BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ

    MDR report key: 3984608 · Received August 6, 2014

    Report

    Report Number
    9612392-2014-00011
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    May 15, 2006
    Report Date
    July 8, 2014
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DEFINITIVE REPORT. THIS CASE IS LISTED IN MAUDE DATABASE OF THE FDA SITE AS MW5036419.

    Description of Event or Problem · 1

    ON (B)(6) 2006 A PATIENT WHO HAD SEVERE KNEE PAIN AND A CANDIDATE FOR A KNEE REPLACEMENT SURGERY RECEIVED SUPARTZ INJECTION FIRST. ON (B)(6)2006 IMMEDIATELY AFTER RECEIVING THE SECOND INJECTION, HE/SHE COULD BARELY WALK OUT OF THE DOCTOR'S OFFICE, BECAUSE OF SEVERE PAIN. THE PHYSICIAN TOLD THE PATIENT TO GO HOME AND PUT ICE ON THE INJECTION SITE. HE/SHE DID THAT AND THERE WAS VERY LITTLE RELIEF OF THE PAIN. ON (B)(6) 2006 A FEW DAYS LATER, HE/SHE WAS GIVEN AN ULTRASOUND, WHICH RULED OUT A BLOOD CLOT. HE/SHE WAS ADMITTED TO THE HOSPITAL AND REMAINED THERE FOR 10 DAYS. ON THE 7TH OR 8TH DAY, HE/SHE HAD TO HAVE SURGERY TO CLEAN OUT THE ARE OF THE INFECTION SINCE IT WOULD NOT HEAL. HE/SHE SPENT SEVERAL WEEKS AT HOME WITH A PIC LINE TO CONTINUE THE HEALING OF THE INJECTION. ON (B)(6) 2014 HE/SHE HAVE BEEN DIAGNOSED WITH LYMPHEDEMA IN THE SAME LEG THAT HAD THE CELLULITIS. HE/SHE HAD TO HAVE AN ULTRASOUND, CT SCAN AND AN MRI TO VERIFY THE CONDITION. HE/SHE ALSO HAVE HAD TO HAVE TWO WEEKS OF PHYSICAL THERAPY BECAUSE OF THE LARGENESS OF THE LEG AND TO TRY AND AID THE LYMPH NODES TO DO THEIR JOB. NOW THAT THE THERAPY IS DONE AND THE SWELLING IS REDUCED, HE/SHE IS NOW REQUIRED TO DO THE MASSAGE OWN SELF ON THE LEFT SIDE AND WEAR COMPRESSION SOCKS EVERYDAY FOR THE REST OF THE LIFE. ON (B)(6) 2014 HE/SHE REPORTED THIS EVENT TO FDA (REPORT NUMBER: MW5036419).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460540 SUPARTZ ACID, HYALURONIC, INTRAARTICULAR MOZ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization