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

Device Problem Off-Label Use (1494)

Patient Problem No Information (3190)

Event Date 08/05/2018

Event Type  Injury  

Event Description

Synvisc one was prescribed for an off label use.Medication will be injected into the left ankle.Dates of use: 1 day.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: 7768254
• MDR Text Key: 116717286
• Report Number: MW5078946
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 08/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• 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: 47 YR