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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS (BIO TECHNOLOGY GENERAL LTD EUFLEXXA 1% SODIUM HYALURONATE

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FERRING PHARMACEUTICALS (BIO TECHNOLOGY GENERAL LTD EUFLEXXA 1% SODIUM HYALURONATE Back to Search Results
Lot Number H13452A
Device Problem Improper Flow or Infusion (2954)
Patient Problems Infiltration into Tissue (1931); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)
Event Date 06/05/2014
Event Type  Injury  
Event Description
Orthopedist's office i had a p.A.Administer and injected euflexxor into both knees.Apparently the medication did not go into the knee joints but rather into the surrounding tissue, causing severe pain and swelling and great difficulty in walking, symptoms still persist when i was scheduled for the series of injections over a 3 week period, the office nurse gave me 2 boxes for the second and third week, as the first injections med was already in the office.I was told to bring a box (which continued 2 prefilled syringe) each time i returned - the only box which i currently have is the one scheduled for inj #3 which didn't take.Atic injections.Strength: prefilled syringe 2ml.Frequency: series of 3 injections given at 1 week intervals.Date the person first started taking the product: (b)(6) 2014, the person stopped taking of product: (b)(6) 2014.Bilateral osteoarthritis and joint problems knees.
 
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Brand Name
EUFLEXXA 1% SODIUM HYALURONATE
Type of Device
EUFLEXXA 1% SODIUM HYALURONATE
Manufacturer (Section D)
FERRING PHARMACEUTICALS (BIO TECHNOLOGY GENERAL LTD
MDR Report Key3999744
MDR Text Key15322717
Report NumberMW5037695
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 07/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date12/01/2014
Device Lot NumberH13452A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/05/2014
Patient Sequence Number1
Treatment
MIRALAX; CA/MAG SUPPLEMENT CALCIUM; BUT STAFFED AFTER BED SHOWED ULCERS); SYMBICORT INHALER; (AT TIME OF INCIDENT WAS TAKING BUT PROFER; AS ABOVE: SUPROFEN; SIMETHICONE; OCUVITE; BENICAR; LIBRAX; XANAX PRN
Patient Outcome(s) Disability;
Patient Age79 YR
Patient Weight68
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