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

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

Patient Problems Bacterial Infection (1735); Fever (1858); Inflammation (1932); Chills (2191); Swelling/ Edema (4577)

Event Date 02/06/2003

Event Type  Injury  

Event Description

Pierre received shot 2 or 3 of synvisc in his knee.In less than 24 hours his leg was swollen and inflamed and he had a high fever and chills.The infection was an invasive type a strep that had been introduced by the shot.He required 3 surgeries on his knee and was hospitalized 2 1/2 weeks, four days of which were in icu.He was very close to death for four days.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10816348
• MDR Text Key: 216103622
• Report Number: MW5097748
• 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: Unknown
• Type of Report: Initial
• Report Date: 02/27/2003
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 84