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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 Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Urticaria (2278); Reaction (2414)
Event Date 09/12/2019
Event Type  Injury  
Event Description
Pt was administered gel one injections in both knees. No apparent adverse reaction at the time of the injection; no know egg or chicken allergy / sensitivities. Pt was seen at er for apparent anaphylactic reaction (hives, breathing difficulty), he was not in shock. Treated with steroids, etc and discharged.
 
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Brand NameGEL-ONE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORP. TAKAHAGI PLANT
MDR Report Key9075861
MDR Text Key159012913
Report NumberMW5089820
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 Other Health Care Professional
Type of Report Initial
Report Date 09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
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: 09/16/2019 Patient Sequence Number: 1
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