MAUDE Adverse Event Report: GENZYME CORP. SYNVISC INJ 8MG/ML (3X2ML) ; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problem Missed Dose (2561)

Event Date 04/02/2020

Event Type  Injury  

Event Description

Patient received the first two doses of her synvisc for her right knee for osteoarthritis but due to covid19, she was unable to receive the remaining injection.Patient was concerned about her therapy and the stability of the medication.Advised the patient the medication will still be stable at room temperature up until the expiration date.Regarding patient's therapy, she might not experience the full benefits since she didn't get all 3 doses.

• Brand Name: SYNVISC INJ 8MG/ML (3X2ML)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORP.
• MDR Report Key: 9932900
• MDR Text Key: 186779199
• Report Number: MW5094044
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009001
• UDI-Public: 58468009001
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR