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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 00-1111-001-00
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 04/07/2022
Event Type  Injury  
Event Description
It was reported that the patient had gel one injection in the left knee.Subsequently, the patient is experiencing extreme pain when standing or walking and discomfort since the injection.No additional patient consequences were reported.
 
Event Description
Upon receipt of additional information, it has been determined that there was no medical intervention reported.The initial report was forwarded in error and should be voided.
 
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Brand Name
GEL-ONE X-LINKED HYALUR 3ML
Type of Device
BIOLOGICS
Manufacturer (Section D)
SEIKAGAKU CORPORATION
6-1, marunouchi
1-chrome chiyoda-ku, tokyo
MDR Report Key14187098
MDR Text Key289901047
Report Number0001822565-2022-01087
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier04987541300911
UDI-Public(01)04987541300911
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number00-1111-001-00
Device Catalogue Number00111100100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/29/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/22/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/30/2022
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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