MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC 16MG/2ML MG/ML - MILLIGRAMS PER MILLILITRES; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Inflammation (1932); Discomfort (2330)

Event Date 12/28/2022

Event Type  Injury  

Event Description

This is a pleasant 60-year-old female who comes in after the second injection of synvisc into the bilateral knees last week for the third injection and states she had a very difficult time after the last injections, she really could not get out of bed or weight-bear for a day.She has significant swelling, no obvious redness.This lasted a couple of days and has improved, there is certainly not back to preinjection levels but she stated that this was far worse than after the first synvisc series 2 weeks ago which she also had some discomfort and intolerance.She has had these in the past and did well with them.She states no poultry or egg allergy/intolerance.She has been icing, using over-the-counter anti-inflammatories and tylenol.She does not feel that the knees are back to her preinjection's level yet.No history of anaphylaxis.Diagnosis for use: bilateral osteoarthritis.

• Brand Name: SYNVISC 16MG/2ML MG/ML - MILLIGRAMS PER MILLILITRES
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 16427593
• MDR Text Key: 310193454
• Report Number: MW5115110
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 02/17/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2023
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White