BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 563290 · Received December 13, 2004

    Report

    Report Number
    2410673-2004-00015
    Event Type
    Injury
    Date Received
    December 13, 2004
    Date of Event
    September 9, 2004
    Report Date
    December 13, 2004
    Manufacturer
    FIDIA SPA
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT WHO RECEIVED TREATMENT IN THE LEFT KNEE WITH HYALGAN (HYALURONATE SODIUM, LOT N008-9149-01) IN SEPT 2004, CALLED THEIR PHYSICIAN LATER THAT DAY TO REPORT THAT PT WAS EXPERIENCING EXTREME SWELLING, PAIN, AND AN INABILITY TO WALK "ONLY WITH THE GREATEST MENTAL ENERGY WAS PT ABLE TO TAKE STEPS ABOUT A QUARTER INCH." PT STAYED IN BED ABOUT A WEEK WITH ICE PACKS, AND WAS TOLD BY THEIR PHYSICIAN TO "NEVER USE THIS DRUG AGAIN." PT HAD BEEN PREVIOUSLY TREATED WITH A SERIES OF SYNVISC (HYALURONATE SODIUM) INJECTIONS 4 TO 5 YEARS AGO AND HAD HIGHLY SUCCESSFUL RESULTS, ALTHOUGH IT WAS MINIMALLY PAINFUL FOR "A WEEK OR SO." THE CONSUMER REPORTED THAT THIS WAS A DISABILITY AND THAT PT HAD TO USE A CANE FOR A WEEK. THE LOT NUMBER OF HYALGAN WAS 0008-9149-01. THE PT CLARIFIED THAT THE EVENTS OCCURRED IN 2004 [PREVIOUSLY REPORTED AS 9/8/04] AND THAT PT RECOVERED A FEW WEEKS LATER. PT ALSO STATED THAT AFTER A PREVIOUS HYALGAN INJECTION IN SEPT 2004, PT HAD DEVELOPED SOME PAIN AND SWELLING HOWEVER NOT TO THE EXTENT AS AFTER THE SECOND INJECTION CORRECTIVE TREATMENT: ICE PACKS.

    Description of Event or Problem · 1

    WOMAN WHO RECEIVED TREATMENT IN THE LEFT KNEE WITH HYALGAN (HYALURONATE SODIUM, LOT N008-9149-01) IN 2004, CALLED HER PHYSICIAN LATER THAT DAY TO REPORT THAT SHE WAS EXPERIENCING EXTREME SWELLING, PAIN, AND AN INABILITY TO WALK "ONLY WITH THE GREATEST MENTAL ENERGY WAS SHE ABLE TO TAKE STEPS ABOUT A QUARTER INCH." SHE STAYED IN BED ABOUT A WEEK WITH ICE PACKS, AND WAS TOLD BY HER PHYSICIAN TO "NEVER USE THIS DRUG AGAIN." SHE HAD BEEN PREVIOUSLY TREATED WITH A SERIES OF SYNVISC (HYALURONATE SODIUM) INJECTIONS 4 TO 5 YEARS AGO AND HAD HIGHLY SUCCESSFUL RESULTS, ALTHOUGH IT WAS MINIMALLY PAINFUL FOR "A WEEK OR SO." THE CONSUMER REPORTED THAT THIS WAS A DISABILITY AND THAT SHE HAD TO USE A CANE FOR A WEEK. THE LOT NUMBER OF HYALGAN WAS 008-9149-01. THE PT CLARIFIED THAT THE EVENTS OCCURRED IN 2004 AND THAT SHE RECOVERED A FEW WEEKS LATER. SHE ALSO STATED THAT AFTER A PREVIOUS HYALGAN INJECTION ABOUT A WEEK EARLIER, SHE HAD DEVELOPED SOME PAIN AND SWELLING HOWEVER NOT TO THE EXTENT AS AFTER THE SECOND INJECTION. THE PT CONFIRMED THE SEQUENCE OF EVENTS AS REPORTED PREVIOUSLY, SAYING THAT SHE BELIEVED THAT THE INJECTION IN 2004 WAS HYALGAN BECAUSE THE DOCTOR HAD TOLD HER HE HAD NO SYNVISC AVAILABLE THAT DAY, AND THAT PREVIOUS INJECTIONS OF SYNVISC HAD NEVER PRODUCED SUCH A PAINFUL REACTION. SHE CONFIRMED THE ADVERSE EVENTS OF PAIN, SWELLING AND INABILITY TO WALK, WHICH ALL RESOLVED COMPLETELY IN ONE WEEK WITH SYMPTOMATIC CARE. SHE HAD COMP;LETED THE MEDWATCH FORM RECEIVED IN DEC-2004 (DELETED CAS R03200400069) WITH INFORMATION FROM MEMORY AND THE LOT NUMBER FROM THE DOCTOR'S OFFICE. THE PT IS UNCERTAIN WHO TOLD HER THAT THE SUSPECT DRUG WAS HYALGAN, HOWEVER THIS WAS HER BELIEF. SHE ACKNOWLEDGED RECEIVING A PHONE CALL FROM A SANOFI PRODUCT SAFETY SPECIALIST AND TWO FOLLOW-UP LETTERS REQUESTING MORE INFORMATION (BOTH NOT RETURNED BECAUSE, "I TOLD YOU EVERYTHING ALREADY". SHE PROVIDED CONTACT INFORMATION FOR HER PHYSICIAN AT THIS TIME. SHE REPORTED, ADDITIONALLY, THAT SHE IS COMPLETELY RECOVEDRED WITH A SLIGHT SWELLING BEHIND HER LEFT KNEE AND IS RELUCTANT TO HAVE ANY FURTHER INJECTIONS BECAUSE OF THE PREVIOUS EXPERIENCE. SHE REQUESTED A CALL BACK FROM SANOFI SO SHE COULD FIND OUT WHICH PRODUCT WAS ASSOCIATED WITH HER ADVERSE EVENT. THE NURSE CONFIRMED THAT THE PT RECEIVED A LEFT KNEE INJECTION WITH SYNVISC (HYALURONATE SODIUM) LOT N008-9149-01 IN 2004. NO HYALGAN WAS EVER GIVEN TO THIS PATIENT. DOCUMENTATION OF THIS REPORT FROM THE OFFICE WILL BE REQUESTED. THIS CASE WILL THEN BE DELETED FROM THE HYALGAN DATABASE. IN 2005, AN INTERNAL REVIEW SHOWED THAT THE CASE WAS INADVERTENTLY DELETED FROM THE DATABASE EARLIER IN 2005, BEFORE A FOLLOW-UP REPORT AND A WITHDRAWAL REQUEST WAS SENT TO FDA. IN ORDER TO FILE THE FOLLOW-UP INFORMATION, THE DATABASE WAS RECONSTITUTED, VALIDATED AND WAS MADE AVAILABLE FOR PRODUCTION ON 20-OCT-2005. AFTER SUBMISSION, THIS CASE WILL BE DELTED FROM THE DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALGAN INTRA-ARTICULAR INJECTION MOZ FIDIA SPA NI N008-9149-01

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Disability