MAUDE Adverse Event Report: DEPUY MITEC, INC. / ANIKA THERAPEUTICS, INC. MONOVISC INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Pain (1994); Swelling (2091)

Event Date 07/19/2018

Event Type  Injury  

Event Description

Injected with monovisc right knee at dr's office.Later that day, my knee felt like it would explode, was swollen and excruciatingly painful.Almost went to er, could not lay down, sit in chair, walk, bend or straighten knee.This continued for 2 days and i returned to dr who said i had a reaction.I found out that after this injection you are not to stand for more than 1 hour which i was not told by dr, he said i could do anything i wanted.I am now finally able to bend and straighten knee without terrible pain, this lasted from (b)(6) 2018 until (b)(6) 2018.I could not drive for 3 weeks and was crippled all summer and fall.Bad drug.Therapy date: (b)(6) 2018.Reason for use: osteoarthritis of knee.

• Brand Name: MONOVISC INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): DEPUY MITEC, INC. / ANIKA THERAPEUTICS, INC.
• MDR Report Key: 8119775
• MDR Text Key: 129183530
• Report Number: MW5081748
• 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: Patient
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 72