MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Spasm(s) (1966); Pain (1994)

Event Date 09/04/2020

Event Type  Injury  

Event Description

I received my first injection of orthovisc on (b)(6) in my left knee.On (b)(6), i began experiencing knee spasms with excruciating pain.On the pain scale, it was a '12'! i couldn't even move my leg due to every time i did, i'd have spasms.This went on for 12 hours.I had to sleep in the chair because i could not move without having spasms.Needless to say, i did not schedule the other 2 injections.

• Brand Name: ORTHOVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 10711764
• MDR Text Key: 212522252
• Report Number: MW5097343
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 72