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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Swelling (2091); Weakness (2145); Toxicity (2333); Reaction (2414); Ambulation Difficulties (2544)

Event Date 05/17/2018

Event Type  Injury  

Event Description

For 8 years caller received bilateral synvisc one injections every 6 months.On (b)(6) 2018, caller left the dr's office after receiving injection, "feeling funny".Later that night, he began to feel heat, swelling, and weakness in both legs.He was unable to move or walk; his wife gave him fluids and called the dr's office in the morning to report symptoms.Caller began to feel better 24 hrs later, however he still suffers from muscle pain, weakness, and aching.After seeking second opinions from several drs and contacting poison control, caller was informed numerous injections of synvisc is contraindicated due to the increased probability of toxic reaction with each injection.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 7762272
• MDR Text Key: 116610137
• Report Number: MW5078923
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention