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U.S. Department of Health and Human Services

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

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SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL-ONE SYRINGE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
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.
 
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Brand NameGEL-ONE SYRINGE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION, TAKAHAGI PLANT
MDR Report Key11010387
MDR Text Key221533899
Report NumberMW5098335
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received12/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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