MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/22/2020

Event Type  Injury  

Event Description

Patient reported being hospitalized with covid-19 from (b)(6) 2020 to (b)(6) 2020 and also that his synvisc medication is ineffective so his doctor will be prescribing him a new therapy.Diagnosis for use: unilateral primary osteoarthritis right knee.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 11010326
• MDR Text Key: 221518033
• Report Number: MW5098329
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009001
• UDI-Public: 58468-0090-01
• 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
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR