MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE CROSS-LINKED HYALURONATE; ACID, HYALURONIC, INTRAARTICULAR

Model Number 00-1111-001-00

Device Problems Unintended Ejection (1234); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2022

Event Type  malfunction  

Event Description

Patient came to appointment with provider for concerns about left knee pain.After assessment, patient was agreeable to have an injection in the left knee with the gel-one product.The physician opened the packet and the pre-loaded syringe with luer-lock was attached to the adapter and needle for the physician to use.The physician, under sterile technique, inserted the needle into the patient's left knee.When the surgeon went to inject the solution, the solution came out of the sterile device at the connection of the luer-lock and adapter causing this area to separate and leaving the sterile needle inserted into the left knee.The physician removed the needle that was in the left knee.A new gel one syringe was obtained and used.There was no injury to the patient.

• Brand Name: GEL-ONE CROSS-LINKED HYALURONATE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 101 constitution avenue; nw/suite 900; washington DC 20001
• MDR Report Key: 15619276
• MDR Text Key: 301898878
• Report Number: 15619276
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Device Lot Number: 0022E17G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2022
• Event Location: Other
• Date Report to Manufacturer: 10/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Male