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

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

Event Type  Injury  

Event Description

After 2 weeks - pt disappointed that the synvisc one hasn't started working yet.Dates of use: 2 weeks.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 CORPORATION
• MDR Report Key: 7637718
• MDR Text Key: 112498059
• Report Number: MW5078037
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR