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

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

Patient Problems Headache (1880); Nausea (1970); Pain (1994); Chills (2191); Shaking/Tremors (2515)

Event Date 02/01/2001

Event Type  No Answer Provided  

Event Description

Took 3 shots in knee 1st and 2nd were perfect; 3rd right swelling, big red areas, headache, nausea, shaking, pain, chills, in bed for weeks.Now walk with a cane."what letter¿ "i¿m out going to allergist, and pain doctor ¿ internist.Nightmare results from the 3rd shot i requested to dr (b)(6) and then to company of synvisc then to fda.Wash increase at what could stopped the numbers of cases the reported problems.If i had been told all of this with my allergist i never could have tried.Asked dr to ¿cr¿ records in this office before i start ¿ only asked if i was allergic to eggs, answer no.".

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10816294
• MDR Text Key: 216115779
• Report Number: MW5097745
• 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: Patient
• Type of Report: Initial
• Report Date: 05/27/2001
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Other
• Patient Age: 80 YR
• Patient Weight: 98