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U.S. Department of Health and Human Services

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

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SEIKAGAKU CORP., TAKAHAGI PLANT GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Nonstandard Device (1420)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2019
Event Type  Injury  
Event Description
Prescriber is aware gel-one not indicated in mfr's guidelines for injection in shoulder.
 
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Brand Name
GEL-ONE
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORP., TAKAHAGI PLANT
MDR Report Key8793562
MDR Text Key151312184
Report NumberMW5088138
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier87541030091
UDI-Public87541030091
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 07/09/2019
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? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/15/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age56 YR
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