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

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.

Event Description

No additional event information is available at the time of this report.

• Brand Name: GEL-ONE
• Type of Device: BIOLOGICS
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 6-1, marunouchi; 1-chrome chiyoda-ku, tokyo
• MDR Report Key: 8822150
• MDR Text Key: 152061593
• Report Number: 0001822565-2019-03119
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 00087541300912
• UDI-Public: (01)00087541300912(11)190320(10)0019C20G
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• 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 Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male