MAUDE Adverse Event Report: IBSA FARMACEUTICI ITALIA SRL GELSYN-3 INJ 16.8 / 2ML; ACID HYALURONIC INTRAARTICULAR

Device Problem Off-Label Use (1494)

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

Event Date 07/29/2019

Event Type  Injury  

Event Description

(b)(6) at dr's office confirmed that dr would like off labeled dose of a 4 week therapy even though 3 weeks is recommended.

• Brand Name: GELSYN-3 INJ 16.8 / 2ML
• Type of Device: ACID HYALURONIC INTRAARTICULAR
• Manufacturer (Section D): IBSA FARMACEUTICI ITALIA SRL
• MDR Report Key: 8860948
• MDR Text Key: 153401629
• Report Number: MW5088731
• Device Sequence Number: 0
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• 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: 70 YR