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

Model Number	00-1111-001-00
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the patient that her leg was crippled and she could not walk for several months post injection.The patient is still wearing a brace.No additional patient consequences were reported.
Event or Problem Description
No additional event information is available at the time of this report.

• 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: 14249870
• Report Number: 0001822565-2022-01214
• Device Sequence Number: 4397905
• Product Code: MOZ
• UDI-Device Identifier: 04987541300911
• UDI-Public: (01)04987541300911
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2023
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00111100100
• Device Lot Number: 0021G29G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/23/2022
• 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: 04/29/2022
• Supplement Report FDA Received Date: 06/03/2022
• 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: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Female