MAUDE Adverse Event Report: SANOFI GENZYME CORPORATION SYNVISC ONE (HYLAN G-F 20); ACID, HYALURONIC, INTRAARTICULAR

Lot Number 8RSL028

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

Patient Problems Aspiration/Inhalation (1725); Pain (1994)

Event Date 09/19/2018

Event Type  Injury  

Event Description

Synvisc-one injected into bilateral knees on (b)(6) 2018.Pt reported symptoms on (b)(6) 2018 (bilateral knee pain and swelling).Bilateral knees aspirated on (b)(6) 2018 for 90 ml of straw colored fluid each knee.Dose or amount: 6 ml millilitre(s); frequency: once; route: intraarticular.

• Brand Name: SYNVISC ONE (HYLAN G-F 20)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SANOFI GENZYME CORPORATION
• MDR Report Key: 8014554
• MDR Text Key: 125597107
• Report Number: MW5080895
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 5846800903
• UDI-Public: 58468-0090-3
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2018

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?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2021
• Device Lot Number: 8RSL028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 79