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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML ACID, HYALURONIC, INTRAARTICULAR

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SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Catalog Number 00111100100
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Swelling (2091); Cramp(s) (2193); Reaction (2414); Alteration In Body Temperature (2682); No Code Available (3191)
Event Date 08/01/2019
Event Type  Injury  
Event Description
It was reported that the patient had pain, swelling, cramps in legs, cold feet, hot legs, electrical shock feeling post gel-one injection on left knee. No additional patient consequences were reported.
 
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Brand NameGEL-ONE X-LINKED HYALUR 3ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION
6-1, marunouchi
1-chrome chiyoda-ku, tokyo 100-0 005
JA 100-0005
MDR Report Key9083555
MDR Text Key162448524
Report Number0001822565-2019-04036
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00111100100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/11/2019
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/18/2019 Patient Sequence Number: 1
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