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U.S. Department of Health and Human Services

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

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SEIKAGAKU CORPORATION GEL-ONE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Model Number 00-1111-001-00
Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)
Patient Problem Autoimmune Reaction (1733)
Event Date 08/11/2019
Event Type  Injury  
Manufacturer Narrative
This case was received by seikagaku corporation on november 6, 2019 from the fda as mw5090541 dated october 29, 2019. We attempt to contact the reporter through our us partner.
 
Event Description
2019-unk - a patient had gel-one injection in the right knee for osteoarthritis. The patient felt fine, injection site was slightly sore. 2019-unk - the patient began feeling achy (flu like). The patient had a fever and a red rash going down the right leg. 2019-unk - the patient was hospitalized with a 103 degrees [fahrenheit] fever, the rash moving from the right leg to the abdomen, right and left buttocks and left leg to the knee. Rash was very very painful and spreading more each day. The patient spent 6 days in the hospital. 2019-unk - infectious disease specialists tested for all types of tick borne illnesses and those were negative. Many biopsies also. "sweet syndrome" was the final diagnosis. Autoimmune reaction to the gel-one injection.
 
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Brand NameGEL-ONE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION
marunouchi center building
6-1, marunouchi 1-chome
chiyoda-ku, tokyo 100-0 005
JA 100-0005
Manufacturer (Section G)
SEIKAGAKU CORPORATION - TAKAHAGI PLANT
258-5, aza-matsukubo
oaza-akahama
takahagi-shi, ibaraki 318-0 001
JA 318-0001
Manufacturer Contact
pharmacovigilance dept.
marunouchi center building
6-1, marunouchi 1-chome
chiyoda-ku, tokyo 100-0-005
JA   100-0005
MDR Report Key9397160
MDR Text Key168776369
Report Number9612392-2019-00018
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number00-1111-001-00
Device Catalogue Number00-1111-001-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/02/2019 Patient Sequence Number: 1
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