MAUDE Adverse Event Report: GENZYME CORP. SYNVISC-ONE, 48 MG

Lot Number 5RSF004

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Missed Dose (2561)

Event Date 10/21/2018

Event Type  Injury  

Event Description

Pt reported 2 recent hospitalizations (b)(6) 2018 and (b)(6) 2018 for liver issues.(b)(6) has not sent synvisc one since (b)(6) 2016.Dose or amount: 48 mg; frequency: inject once; route: injection.Dates of use: (b)(6) 2016.Diagnosis or reason for use: osteoarthritis of knee.

• Brand Name: SYNVISC-ONE, 48 MG
• Type of Device: SYNVISC-ONE, 48 MG
• Manufacturer (Section D): GENZYME CORP.
• MDR Report Key: 8194387
• MDR Text Key: 131593346
• Report Number: MW5082533
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468009003
• 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: 12/13/2018

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: 04/30/2018
• Device Lot Number: 5RSF004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 66 YR