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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET / SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL-ONE ACID, HYALURONIC, INTRAARTICULAR

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ZIMMER BIOMET / SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL-ONE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number 0020G20G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)
Event Date 10/20/2020
Event Type  Injury  
Event Description
Patient received gel-one injection into her left knee on (b)(6) 2020. She reports that approximately 3-4 days later she developed itchy skin, and then developed hives and a red, bumpy rash all over her body (except her face). She has been on numerous rounds of steroids, antihistamines, creams, etc. And has not had any relief of symptoms. She has stopped other medications that she had been on and her other physicians have ruled out any medication reactions.
 
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Brand NameGEL-ONE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
ZIMMER BIOMET / SEIKAGAKU CORPORATION, TAKAHAGI PLANT
MDR Report Key10976320
MDR Text Key220762597
Report NumberMW5098277
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 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number0020G20G
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: 12/08/2020 Patient Sequence Number: 1
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