MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC INJ 8MG/ML(3X2ML)*; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Missed Dose (2561)

Event Date 03/11/2020

Event Type  Injury  

Event Description

Spoke with patient.He stated that he never received week 4 dose that was shipped to mdo on (b)(6) due to mdo being closed.He is 2 weeks late on his 2nd dose.Missed dose consult done and advised patient that label will be for maintenance dose due to 2nd dose week 4 had been shipped to mdo.Dates of use: (b)(6) 2020 - present.Ae record id: (b)(4).

• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 9983077
• MDR Text Key: 188890476
• Report Number: MW5094209
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009001
• UDI-Public: 58468009001
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• 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?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR