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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 01/10/2019

Event Type  Injury  

Event Description

Office confirmed off label use for injection into the right hip.

• Brand Name: GEL-ONE INJ 30MG/3ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP., TAKAHAGI PLANT
• MDR Report Key: 8253063
• MDR Text Key: 133462457
• Report Number: MW5083135
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 87541030091
• UDI-Public: 87541030091
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• 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