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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Reaction (2414); Ambulation Difficulties (2544)

Event Date 11/01/2017

Event Type  Injury  

Event Description

Patient believes she was injected with a recalled batch and experienced an adverse reaction in her left knee hours after the injection.Patient was injected in both knees, however isn't sure if it was from the same recalled lot.She reports having difficulty standing and severe pain causing her to stay in bed for a week.Patient read about the recall in an article in the (b)(6) stating some kind of microbe contamination.Her physician reported this event to the manufacturer as well.

• Brand Name: SYNVISC-ONE SANOFI
• Type of Device: ACID, HYALURONIC INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORP.
• MDR Report Key: 7227911
• MDR Text Key: 98678468
• Report Number: MW5074958
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/29/2018

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?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR