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

Lot Number SRSA004

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

Patient Problems Cyst(s) (1800); Pain (1994); Swelling/ Edema (4577)

Event Date 09/25/2015

Event Type  Injury  

Event Description

Patient reported having second does of 3 does series of synvisc on (b)(6) 2015.Afterwards, her knee become swollen and the back of the knee was very painful.The patient things this is a baker's cyst and not related to synvisc.Md.(b)(6).

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10811051
• MDR Text Key: 215611340
• Report Number: MW5097716
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009001
• UDI-Public: 58468-0090-01
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/28/2015

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
• Device Operator: No Information
• Device Expiration Date: 02/28/2018
• Device Lot Number: SRSA004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR