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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

Spontaneous call in from patient, stated that gel one didn't work for him, he has no improvement, he got the injection on (b)(6) 2020 and doctor told him it takes 2 to 7 days to see improvement, and it has been 9 days now and patient has no improvement.Patient has sent emails to doctor's office to let them know and he's still waiting for an answer.Reported to (b)(6) by pt/caregiver.

• Brand Name: GEL-ONE SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 11010387
• MDR Text Key: 221533899
• Report Number: MW5098335
• 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: 11/27/2020

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2020
• Patient Sequence Number: 1