MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE 48MG/6ML SYR; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Pt reported that she was hospitalized and had jaw surgery.(b)(6) needs to schedule delivery with modification and delivery order as soon as possible, pt is in severe pain.(b)(6) has never filled this medication for pt.Md: (b)(6).

• Brand Name: SYNVISC ONE 48MG/6ML SYR
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 11495649
• MDR Text Key: 240438936
• Report Number: MW5100012
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468009003
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization