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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 Problem Insufficient Information (3190)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
This is a definitive report. This case is received by seikagaku corporation on (b)(6) 2018 from the fda mw5078158 dated (b)(6) 2018. (b)(4).
 
Event Description
A female patient who received gel-one injection in the knee. The patient had a knee surgery. Event outcome was reported as "hospitalization" by the reporter.
 
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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 Key7745087
MDR Text Key115896237
Report Number9612392-2018-00012
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P080020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
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
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/12/2018
Event Location No Information
Date Manufacturer Received07/10/2018
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: 08/02/2018 Patient Sequence Number: 1
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