MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML; BIOLOGICS

Model Number	N/A
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient is in pain.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The patient confirmed the full dose of the product was not injected.The patient's pain is due to the underlying condition and not the device.The initial report was forwarded in error and should be voided.

• Brand Name: GEL-ONE X-LINKED HYALUR 3ML
• Common Device Name: BIOLOGICS
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 6-1, marunouchi; 1-chrome chiyoda-ku, tokyo
• MDR Report Key: 16209084
• Report Number: 0001822565-2023-00129
• Device Sequence Number: 5382677
• Product Code: MOZ
• UDI-Device Identifier: 04987541300911
• UDI-Public: (01)04987541300911(17)240509(10)0022B16G
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2024
• Device Model Number: N/A
• Device Catalogue Number: 00111100100
• Device Lot Number: 0022B16G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/13/2023
• 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: 01/19/2023
• Supplement Report FDA Received Date: 02/08/2023
• Date Device Manufactured: 02/16/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 49 KG