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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Spontaneous: ibc from (b)(6), (senior patient coordinator).Received new order of orthovisc and reported being changed to orthovisc because patient had an allergic reaction to synvisc.Type of reaction unknown but md wants to change to orthovisc.No other information obtained.Reported to (b)(6) by health professional.

• Brand Name: SYNVISC (3X2ML PREFILLED SYR)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 13334311
• MDR Text Key: 284453054
• Report Number: MW5106907
• Device Sequence Number: 1
• 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: 01/19/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2022
• Patient Sequence Number: 1
• Patient Sex: Female