MAUDE Adverse Event Report: SEIKAGAKU CORPORATION TAKAHASI PLANT GEL-ONE INJ 30MG/3ML ; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Off-Label Use (1494)

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

Event Date 11/06/2019

Event Type  No Answer Provided  

Event Description

The dr has approved the use of gel-one to be injected into the pt's ankle; however, this is off label for this medication.

• Brand Name: GEL-ONE INJ 30MG/3ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION TAKAHASI PLANT
• MDR Report Key: 9317837
• MDR Text Key: 166738156
• Report Number: MW5091064
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 87541030091
• UDI-Public: 87541030091
• Combination Product (y/n): Y
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR