MAUDE Adverse Event Report: SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL ONE SYRINGE 30MG3ML ACID, HYALURONIC, INTRAARTICULAR

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Patients spontaneously called pharmacy questioning if there's any alternative therapy for gel one. Pt states gel one is not helping her symptoms, the pain is "really bad". Md is not aware. Patient will discuss with md. Advised patient there are many similar products with one or multiple injections. Patient understood. No other information available. Reported to (b)(6) by pt/caregiver.

• Brand Name: GEL ONE SYRINGE 30MG3ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 10091682
• MDR Text Key: 192630732
• Report Number: MW5094685
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 05/18/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage