MAUDE Adverse Event Report: GENZYME SYNVISC; ACID, HYALURONIC

Lot Number 7RSL044

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Arthralgia (2355)

Event Date 06/05/2018

Event Type  Injury  

Event Description

Patient stated that both of her knees became very swollen with fluid build up after receiving the synvisc injections.She said they were warm and painful to the touch and reports a hospitalization from (b)(6) 2018.Dose or amount: 48 mg/milligrams.Frequency: other.Route: intra-articular.Therapy start date: (b)(6) 2018.Unilateral primary osteoarthritis.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC
• Manufacturer (Section D): GENZYME
• MDR Report Key: 7613461
• MDR Text Key: 111710995
• Report Number: MW5077926
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468-0090-03
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/10/2020
• Device Lot Number: 7RSL044
• 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: 68 YR