MAUDE Adverse Event Report: SANOFI GENZYME SODIUM HYALURONIC ACID; SYNVISC INJECTION / HYALURONIC ACID

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Chills (2191); Myalgia (2238); Reaction (2414); Sweating (2444)

Event Date 08/10/2018

Event Type  Injury  

Event Description

Caller visited her dr on (b)(6) 2018 for a synvisc injection to the knee.Several hours later, pt began to react to the injection with extreme swollen knee and calf and pain in the leg.She contacted the emergency number to her dr's office and was advised to take some advil and elevate the leg, and come in on monday to see the dr.She met with the dr three days later and a doppler test was performed, and the result came back negative.It took about a week for the pain and swelling to begin to subside.On the (b)(6), pt started experiencing night sweats accompanied with body ache and chills.On the (b)(6), pt went to the emergency room and it was confirmed she has an allergic reaction to the injection; since her symptoms persist she was admitted and further test was done, but all came back negative.Pt later discovered that the injection was recalled in 2017.

• Brand Name: SODIUM HYALURONIC ACID
• Type of Device: SYNVISC INJECTION / HYALURONIC ACID
• Manufacturer (Section D): SANOFI GENZYME
• MDR Report Key: 7864434
• MDR Text Key: 119966504
• Report Number: MW5079691
• 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: Patient
• Type of Report: Initial
• Report Date: 09/09/2018

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?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 70