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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIDIA PHARMA USA, INC HYMOVIS ACID, HYALURONIC, INTRA ARTICULAR

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FIDIA PHARMA USA, INC HYMOVIS ACID, HYALURONIC, INTRA ARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Pain (1994); Dizziness (2194); Joint Swelling (2356); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
Received hymovis injections (bi-lateral) and suffered severe side effects requiring an er visit & several knee aspirations to remove excessive fluids (over 200cc's). After the second injection i felt physically ill, dizzy/nauseous, etc. Additionally, my knee pain became severe enough that i could no longer walk unassisted. My knees became swollen, painful & felt unsteady. I have used several fiscal supplements in the past with positive effects. I had moderate arthritis but after using hymovis it feels like it drastically sped the arthritic process of both of my knees. This product should be immediately removed from the market.
 
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Brand NameHYMOVIS
Type of DeviceACID, HYALURONIC, INTRA ARTICULAR
Manufacturer (Section D)
FIDIA PHARMA USA, INC
MDR Report Key9774592
MDR Text Key181784421
Report NumberMW5093397
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/26/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/28/2020 Patient Sequence Number: 1
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