MAUDE Adverse Event Report: SEIKAGAKU CORP., TAKAHAGI PLANT GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Nonstandard Device (1420)

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

Event Date 07/09/2019

Event Type  Injury  

Event Description

Prescriber is aware gel-one not indicated in mfr's guidelines for injection in shoulder.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP., TAKAHAGI PLANT
• MDR Report Key: 8793562
• MDR Text Key: 151312184
• Report Number: MW5088138
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR