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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML BIOLOGICS

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SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML BIOLOGICS Back to Search Results
Catalog Number 00111100100
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Urticaria (2278); Reaction (2414)
Event Date 09/12/2019
Event Type  Injury  
Event Description
It was reported that post gel one injection in both knees, the patient went to emergency for apparent anaphylactic reactions such as hives and breathing difficulty. The patient was treated with steroids and discharged. No additional patient consequences were reported.
 
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Brand NameGEL-ONE X-LINKED HYALUR 3ML
Type of DeviceBIOLOGICS
Manufacturer (Section D)
SEIKAGAKU CORPORATION
6-1, marunouchi
1-chrome chiyoda-ku, tokyo 100-0 005
JA 100-0005
MDR Report Key9857146
MDR Text Key191863668
Report Number0001822565-2020-01023
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
Type of Report Initial
Report Date 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00111100100
Device Lot Number0019F07G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/18/2020
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

Patient Treatment Data
Date Received: 03/19/2020 Patient Sequence Number: 1
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