MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Nausea (1970)

Event Date 02/25/1998

Event Type  Death  

Event Description

Patient received first of three injectable treatment with synvisc on (b)(6).Second injection was given on (b)(6) 1998.The patient received the injection at approximately 1:45 pm.The patient returned to the nursing home and reported nausea at 4 pm (not an unusual complaint according to reporter).The patient was checked at 8:30 pm and complained of nausea.The patient was found dead at 10:10 pm.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10828834
• MDR Text Key: 216193016
• Report Number: MW5097772
• Device Sequence Number: 2
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/1998
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR