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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE BIOLOGICS

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SEIKAGAKU CORPORATION GEL-ONE BIOLOGICS Back to Search Results
Model Number N/A
Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problem Arthralgia (2355)
Event Date 06/25/2019
Event Type  Injury  
Event Description
It was reported that during a gel-one procedure, the blue flange broke off causing the provider¿s hand to slip with more force downward thus causing the needle to bend in the patient¿s joint. The patient complained of additional pain as a result of this malfunction.
 
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Brand NameGEL-ONE
Type of DeviceBIOLOGICS
Manufacturer (Section D)
SEIKAGAKU CORPORATION
6-1, marunouchi
1-chrome chiyoda-ku, tokyo
MDR Report Key8822150
MDR Text Key152061593
Report Number0001822565-2019-03119
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,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00111100100
Device Lot Number0019C20G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/21/2022
Device Age4 MO
Event Location Hospital
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/24/2019 Patient Sequence Number: 1
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