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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 Off-Label Use (1494)
Patient Problem Pain (1994)
Event Date 07/09/2019
Event Type  Injury  
Event Description
Gel-one off label use for pain in right shoulder, md is aware diagnosis is not indicated by mfr's guideline.
 
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Brand NameGEL-ONE INJ 30MG/3ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORP., TAKAHAGI PLANT
MDR Report Key8803362
MDR Text Key151635433
Report NumberMW5088225
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 07/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2019
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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