MAUDE Adverse Event Report: GENZYME SYNVISC ONE INJ 8MG/ML

Device Problem Insufficient Information (3190)

Patient Problem Arthritis (1723)

Event Date 07/27/2018

Event Type  Injury  

Event Description

Hospitalization per claims information: (b)(4)-unilateral primary osteoarthritis, left hip.Admit (b)(6) 2018 ¿ discharge (b)(6) 2018.Unable to contact pt for details.Dose or amount: 8mg/ml; frequency: other; route: intra-articular.Dates of use: 3 month(s).Diagnosis or reason for use: unilateral primary osteoarthritis."is the product compounded: no.Is the product over-the-counter: no.".

• Brand Name: SYNVISC ONE INJ 8MG/ML
• Type of Device: SYNVISC ONE INJ 8MG/ML
• Manufacturer (Section D): GENZYME
• MDR Report Key: 7739068
• MDR Text Key: 115887540
• Report Number: MW5078735
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/27/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR