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U.S. Department of Health and Human Services

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

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SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL ONE SYRINGE 30MG3ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
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.
 
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Brand NameGEL ONE SYRINGE 30MG3ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION, TAKAHAGI PLANT
MDR Report Key10091682
MDR Text Key192630732
Report NumberMW5094685
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 05/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2020
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

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