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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Patient reported synvisc one needed to be discontinued since the medication did not work.We only shipped the one order that was to be injected into bilateral knees intra-articularly once at physicians office.No other details or information was reported.Route of administration: intra-articularly indication: bilateral primary osteoarthritis of knee and age-related osteoporosis without current pathological fracture.Reported to (b)(6) by pt/caregiver.

• Brand Name: SYNVISC ONE PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 17192252
• MDR Text Key: 317866136
• Report Number: MW5118727
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female