MAUDE Adverse Event Report: GENZYME CORP SYNVISC - ONE; ACID HYALURONIC INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 01/23/2019

Event Type  Death  

Event Description

Pt's wife (b)(6) reported that the pt is now deceased.Bilateral primary osteoarthritis of knee.Dose or amount: 48 mg milligram(s), frequency: other, route: intra-articular.Therapy start date: (b)(6) 2014.

• Brand Name: SYNVISC - ONE
• Type of Device: ACID HYALURONIC INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORP
• MDR Report Key: 8301182
• MDR Text Key: 134977798
• Report Number: MW5083647
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468-0090-03
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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 Outcome(s): Death
• Patient Age: 90 YR