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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 No Display/Image (1183); Device Fell (4014)
Patient Problem Loss of consciousness (2418)
Event Date 06/17/2018
Event Type  Injury  
Manufacturer Narrative
This is a definitive report. This case is received by seikagaku corporation on (b)(6) 2018 from the fda mw5078007 dated (b)(6) 2018. Seikagaku corporation is also submitting this report on behalf of zimmer, inc. As the importer with authorization by the exemption number (b)(4).
 
Event Description
On (b)(6) 2018 - a female patient who received gel-one injection in the left knee on unknown date fell and blacked out. On (b)(6) 2018 - the patient went to er and was treated. Event outcome was reported as "hospitalization" by the reporter, "other health professional". On (b)(6) 2018 - the event was resolved.
 
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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 Key7726479
MDR Text Key115352092
Report Number9612392-2018-00011
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 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
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 Date07/05/2018
Event Location Home
Date Manufacturer Received07/02/2018
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: 07/27/2018 Patient Sequence Number: 1
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