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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORP., TAKAHAGI PLANT GEL-ONE INJ 30MG/3ML ACID, HYALURONIC, INTRAARTICULAR

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SEIKAGAKU CORP., TAKAHAGI PLANT GEL-ONE INJ 30MG/3ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 01/10/2019
Event Type  Injury  
Event Description
Office confirmed off label use for injection into the right hip.
 
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Brand NameGEL-ONE INJ 30MG/3ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORP., TAKAHAGI PLANT
MDR Report Key8253063
MDR Text Key133462457
Report NumberMW5083135
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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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