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

Lot Number Q14105

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

Patient Problems Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 06/10/2015

Event Type  Injury  

Event Description

Patient received second synvisc injection and had lot of pain and swelling that kept her from walking for 2 days.This happened with a previous injection series and it lasted about 2 weeks total.Physician information: (b)(6).

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10811014
• MDR Text Key: 215611029
• Report Number: MW5097714
• 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: 06/12/2015
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2017
• Device Lot Number: Q14105
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 59 YR