BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 2223132 · Received July 25, 2011

    Report

    Report Number
    2244564-2011-00097
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 13, 2011
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY CAUSALITY: POSSIBLE, BASED ON THE INFO AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THIS SERIOUS SPONTANEOUS CASE WAS FROM A NURSE PRACTITIONER IN THE US. THE PT, A (B)(6) CAUCASIAN FEMALE, (B)(6) RECEIVED EUFLEXXA (1% SODIUM HYALURONATE) INTO THE KNEES BILATERALLY AND WAS ADMITTED TO THE HOSP FOR CELLULITIS OF THE RIGHT CALF. ON (B)(6) 2011, THE PT RECEIVED HER FIRST EUFLEXXA INJECTIONS, BILATERALLY INTO THE KNEES. ON (B)(6) 2011, THE PT RECEIVED HER SECOND INJECTIONS BILATERALLY INTO THE KNEES. ON (B)(6) 2011, THE PT WAS ADMITTED TO THE HOSP FOR CELLULITIS OF THE RIGHT CALF AFTER HAVING HAD A SUPERFICIAL SCRATCH OF THE AREA. THE HOSP STAY WAS LESS THAN ONE WEEK (DISCHARGE DATE UNK). THE NURSE PRACTITIONER REPORTED THAT SHE DID NOT FEEL THE HOSPITALIZATION WAS RELATED TO EUFLEXXA. GAUGE AND BRAND OF NEEDLE USED FOR ADMINISTRATION WAS UNK BY THE REPORTER. IT WAS NOT KNOWN IF THERAPY WITH EUFLEXXA CONTINUED. CONCOMITANT MEDICATIONS WERE REPORTED. MEDICAL HISTORY WAS REPORTED AND ALSO INCLUDED PEANUT OIL AND AVOCADO ALLERGY, AND CHRONIC SLOW WOUND HEALING. THE PT WAS A NON-SMOKER AND DID NOT CONSUME ALCOHOL. FURTHER INFO HAS BEEN REQUESTED. IF NEW SIGNIFICANT INFO IS RECEIVED, A RE-EVAL OF THE CASE WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUFLEXXA 1% SODIUM HYALURONATE MOZ

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization VITAMIN B6 50 MG QD| CALTRATE (CALCIUM CARBONATE) 600/400 MG BID| SINGULAIR (MONTELUKAST) Q| 180MG QD| NEXIUM (ESOMEPRAZOLE) 40 MG QD| COUMADIN (WARFARIN) QHS| FENTANYL PATCH Q 3 DAYS| ASCORBIC ACID 500 MG QD| LOPERMAMIDE QD| XOLAIR (OMALIZUMAB) Q3 WEEKS| IRON 325MG TID| DOCUSATE QD| PREDNISONE 30 MG QD| NEURONTIN (GABAPENTIN) 800 MG TID| SPIRIVA (TIOTROPIUM) QD| LIDODERM (LIDOCAINE) QD| ZOCOR (SIMVASTATIN) 50MG QD| PROBIOTIC QD| RECLAST (ZOLEDRONIC ACID) Q YEAR| HYDROCODONE Q6H PRN| ALLEGRA (FEXOFENADINE AND PSEUDOEPHEDRINE)