MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE; BIOLOGICS

Model Number	N/A
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Event or Problem Description
No additional event information is available at the time of this report.

• Brand Name: GEL-ONE
• Common Device Name: BIOLOGICS
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 6-1, marunouchi; 1-chrome chiyoda-ku, tokyo
• MDR Report Key: 8822150
• Report Number: 0001822565-2019-03119
• Device Sequence Number: 16945324
• Product Code: MOZ
• UDI-Device Identifier: 00087541300912
• UDI-Public: (01)00087541300912(11)190320(10)0019C20G
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00111100100
• Device Lot Number: 0019C20G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/21/2022
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male