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

Model Number	00-1111-001-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a definitive report.A series of events on this case is considered to be "required medical or surgical intervention to prevent permanent impairment or damage" and "other serious or important medical events".According to the result of investigation, there were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring for lot# 0023x17g.
Event or Problem Description
(b)(6) 2024 - a female patient received gel-one into the knee for oa.About 1 hour - 1 hour half after, she felt light headed and then started to get hives and throat closing up.She took benadryl and gave herself an epi shot.She then called emergency call #911.(the date is uncertain at this moment, but could be of (b)(6) 2024.) the patient came in with hand gloves and mask indicating she already has severe allergies.She had previous injection of gel-one in (b)(6) 2024 with no issues.She was still having issues that she felt was a result from the injection.

• Brand Name: GEL-ONE
• Common Device Name: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0 005; JA 100-0005
• Manufacturer (Section G): SEIKAGAKU CORPORATION - TAKAHAGI PLANT; 258-5, aza-matsukubo; oaza-akahama; takahagi-shi, ibaraki 318-0 001; JA 318-0001
• Manufacturer Contact: marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005
• MDR Report Key: 20086748
• Report Number: 9612392-2024-00012
• Device Sequence Number: 12685699
• Product Code: MOZ
• UDI-Device Identifier: 04987541300911
• UDI-Public: (01)04987541300911(17)251203(10)0023X17G
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P080020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/28/2024

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: 12/03/2025
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Device Lot Number: 0023X17G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female