MAUDE Adverse Event Report: GENZYME CORP. SYNVISC INJ 8MG/ML (3 X 2 ML); ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problem Missed Dose (2561)

Event Date 08/29/2018

Event Type  Injury  

Event Description

Received enrollment form drug listed on form is synvisc (box checked for synvisc).(b)(6)call stated medication needed was synvisc-one.Took doe for synvisc-one medication has not been given to pt, (b)(6) requesting synvisc-one be shipped.Spoke with (b)(6) at (b)(6).Dates of use: (b)(6) 2018 - present.Diagnosis or reason for use: osteoarthritis.Is the product compounded? no.Is the product over-the-counter? no.

• Brand Name: SYNVISC INJ 8MG/ML (3 X 2 ML)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORP.; 1 research drive; west borough MA 01581
• MDR Report Key: 7850861
• MDR Text Key: 119572340
• Report Number: MW5079617
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009001
• UDI-Public: 58468009001
• Combination Product (y/n): N
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0