MAUDE Adverse Event Report: GENZYME BIOSURGERY SYNVISC; ACID, HYALURONIC

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Swelling (2091); Complaint, Ill-Defined (2331); Reaction (2414)

Event Type  Injury  

Event Description

Patient's doctor reported she had acute local reaction to synvisc injection - stiff, red, hot, and swollen.Patient went to the emergency room.No onset date was provided.Wsp never dispensed synvisc for the patient.Dose or amount: unk.Frequency: unk.Route: unk.Dates of use: unk.Diagnosis or reason for use: loc prim osteoart-l/leg.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC
• Manufacturer (Section D): GENZYME BIOSURGERY
• MDR Report Key: 6885735
• MDR Text Key: 87209867
• Report Number: MW5072268
• 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: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• 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): Hospitalization
• Patient Age: 56 YR