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

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.

• Brand Name: HYMOVIS
• Type of Device: ACID, HYALURONIC, INTRA ARTICULAR
• Manufacturer (Section D): FIDIA PHARMA USA, INC
• MDR Report Key: 9774592
• MDR Text Key: 181784421
• Report Number: MW5093397
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 103