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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION TAKAHAGI PLANT GEL ONE ACID, HYALURONIC, INTRAARTICULAR

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SEIKAGAKU CORPORATION TAKAHAGI PLANT GEL ONE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number LOT 17 D17G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 08/24/2017
Event Type  Injury  
Event Description
Patient received a single hyaluronic injection in her right knee and developed necrotizing pancreatitis within 48 hours. In icu for 7 days and inpatient for additional 14. Zimmer biomet.
 
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Brand NameGEL ONE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION TAKAHAGI PLANT
MDR Report Key9641584
MDR Text Key177024532
Report NumberMW5092572
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
Type of Report Initial
Report Date 01/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/30/2018
Device Lot NumberLOT 17 D17G
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: 01/28/2020 Patient Sequence Number: 1
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