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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
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Complaint, Ill-Defined (2331); Inadequate Pain Relief (2388)
Event Date 07/22/2019
Event Type  Injury  
Event Description
It was reported by the patient that she received gel-one injection, on left knee. Subsequently patient has not had any pain relief. Patient stated she was achy, then muscle spasms, nauseous, and was down the entire week. Started to feel better the following monday. No further pain continued to date. 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 Key8957048
MDR Text Key156328769
Report Number0001822565-2019-03566
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 09/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00111100100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/16/2019
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: 09/03/2019 Patient Sequence Number: 1
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