MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC (3X2ML PREFILLED SYR); ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544); Reaction to Medicinal Component of Device (4574)

Event Date 01/07/2021

Event Type  Injury  

Event Description

Spontaneous: pt had severe reaction to the 2nd and 3rd injection.She experienced pain and swelling.She could not walk on her feet.Reported to (b)(6) by pt/caregiver.

• Brand Name: SYNVISC (3X2ML PREFILLED SYR)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 11236289
• MDR Text Key: 229153981
• Report Number: MW5099015
• Device Sequence Number: 2
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 01/14/2021
• 2 Devices were Involved in the Event: 1 2

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2021
• Patient Sequence Number: 1
• Patient Age: 58 YR