BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 2012952 · Received March 2, 2011

    Report

    Report Number
    9610200-2011-00001
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 21, 2011
    Manufacturer
    FIDIA FARMACEUTICI S.P.A
    Product Code
    MOZ
    PMA / PMN Number
    P950027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO BATCH NUMBER WAS RECEIVED ON THIS COMPLAINT; THEREFORE, NO INVESTIGATION CAN BE CONDUCTED. CONCLUSION: NO INVESTIGATION/NO ASSESSMENT POSSIBLE. CASE STATUS: CLOSED.

    Description of Event or Problem · 1

    CONSUMER REPORT: INITIAL INFO FOR THIS CASE FROM (B)(6) WAS RECEIVED FROM (B)(4) THE LOCAL DISTRIBUTOR FOR HYALGAN ((B)(4)). THE PT CONTACTED (B)(4) BY MAIL AND REPORTED A SIGNIFICANT SWELLING OF THE KNEE AND PAIN ON THE UPPER AND LOWER LIMB. THE PT HAD CONTACTED HER ORTHOPAEDIC DOCTOR DUE TO PROBLEMS WITH HER SPINAL COLUMN. HER DOCTOR RECOMMENDED A SERIES OF HYALGAN INJECTIONS. AFTER THE FIRST INJECTION THE PT INFORMED HER PHYSICIAN THAT SHE WAS EXPERIENCING KNEE SWELLING. SWELLING BECAME SIGNIFICANTLY MORE SIGNIFICANT AFTER THE SECOND INJECTION. THE THIRD HYALGAN INJECTION WAS NOT PERFORMED, AND THE LEFT KNEE WAS ASPIRATED (60 ML YELLOW AND HAZY FLUID - ANALYSIS NOT AVAILABLE). SINCE THAT TIME THE KNEE WAS SIGNIFICANTLY SWOLLEN AND PAINFUL, IT COULD NOT BE COMPLETELY EXTENDED AND BENDED. THE DOCTOR WAS ON HOLIDAYS UP TO THE BEGINNING OF (B)(6). THE PT WAS STRONGLY RECOMMENDED BY (B)(4) TO GO TO ANOTHER ORTHOPAEDIC DOCTOR OR TO A HOSPITAL TO RE-EVALUATE THE KNEE SITUATION. THE PT WAS RECONTACTED BY (B)(4) BY MAIL. SHE DID NOT WANT TO PROVIDE THE NAME OF HER ORTHOPAEDIC DOCTOR. THE FOLLOWING INFO WAS RECEIVED BY MAIL: BOTH KNEES WERE INJECTED IN (B)(6) 2011. LIMITED SWELLING WAS OBSERVED AT THE INJECTION SITE OF BOTH KNEES. ANAMNESTICALLY, BAKER CYSTS HAVE BEEN PRESENT IN BOTH KNEES FOR YEARS, WITHOUT ANY CLINICAL SYMPTOMS. THE SECOND HYALGAN INJECTION SERIES IN BOTH KNEES WERE PERFORMED ON (B)(6) 2011. AFTER TRAINING ON THE HOME BIKE THE RIGHT KNEE DEVELOPED A LIGHT SWELLING, BUT THE LEFT ONE DEVELOPED A SIGNIFICANT SWELLING WITH PAIN AND MOVEMENT DEFICIT. THE THIRD INJECTION IN THE LEFT KNEE, PLANNING FOR (B)(6), WAS NOT PERFORMED. ON THAT DATE, THE LEFT KNEE WAS ASPIRATED (60 ML YELLOW AND HAZY FLUID). A SECOND ASPIRATION WAS DONE ON (B)(6) (AGAIN YELLOW AND HAZY FLUID) AND THE THIRD ONE ON (B)(6) (FLUID CONTAINED BLOOD). HISTOLOGICAL ANALYSIS DID NOT REVEAL ANY BACTERIA. AN MRI HAS BEEN PLANNED FOR (B)(6). THE PT WAS TAKING MAGNESIUM AND CALCIUM ON A REGULAR BASE, OCCASIONALLY: 0,5- 1 TABLET PRAXITEN (OXAZEPAM) TO SLEEP. NO OTHER DISEASES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALGAN INTRA-ARTICULAR INJECTION MOZ FIDIA FARMACEUTICI S.P.A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PRAXITEN (OXAZEPAM) - 0,5-1 TABLET (OCCASIONALLY)| CALCIUM (REGULARLY)| MAGNESIUM (REGULARLY)