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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Local Reaction (2035); Joint Swelling (2356); Ambulation Difficulties (2544)

Event Date 04/16/2020

Event Type  Injury  

Event Description

Patient reports that has not been able to walk after his injection 5 days ago and had to be taken to his car in a wheelchair.He still can't walk today and complained of large knot on the side of his knee that is warm to the touch with pain that radiates throughout his entire leg.

• Brand Name: SYNVISC ONE INJ BMG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 9992311
• MDR Text Key: 188862649
• Report Number: MW5094240
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 92 YR