MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE INJ 8MG/ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Pain (1994)

Event Date 05/30/2019

Event Type  No Answer Provided  

Event Description

The pt stated the injection for the medication was given into the wrong spot in his knee and was not effective.He is requiring another injection of the medication as he is in a lot of pain.

• Brand Name: SYNVISC ONE INJ 8MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 8749401
• MDR Text Key: 149945891
• Report Number: MW5087724
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• 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 Age: 56 YR