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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
Lot Number 0017Z20G
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Tingling (2171)
Event Date 01/28/2019
Event Type  Injury  
Event Description
Pt reports being hospitalized with tingling and pain through entire body. Zimmer biomet.
 
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Brand NameGEL-ONE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORP., TAKAHAGI PLANT
MDR Report Key8523219
MDR Text Key142461263
Report NumberMW5085941
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 04/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/18/2019
Device Lot Number0017Z20G
Was Device Available for Evaluation? No
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?

Patient Treatment Data
Date Received: 04/16/2019 Patient Sequence Number: 1
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