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

Model Number	00-1111-001-00
Health Effect - Clinical Codes	Dyspnea (1816); Erythema (1840); Fatigue (1849); Itching Sensation (1943); Nausea (1970); Pain (1994); Vomiting (2144); Dizziness (2194); Shaking/Tremors (2515); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a gel-one injection on the right knee.Subsequently, the patient experienced swelling, stiffness, pain, difficulty walking, hives, severe itching and redness of the trunk, fatigue, nausea, vomiting, dizziness, tremors, fainting, and dyspnea.Patient was prescribed methylprednisolone and took over the counter benadryl.No additional patient consequences were reported.
Event or Problem Description
No additional event information is available at the time of this report.
Event or Problem Description
It was reported patient had gel one injection in right knee.Within one hour patient started having allergic reaction symptoms with itching, and hives.Patient self-medicated with benadryl which reduced the swelling and itching.Patient later had an episode of syncope, nausea or vomiting.Prescription for medrol pack prescribed.Due to time constraints of acquiring the prescription, symptoms exacerbated to swollen lips and hoarseness.After taking medrol dose, within an hour started feeling normal with exception of not able to sleep due to steroid use resulting in fatigue.No additional patient consequences were reported 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: 14717908
• Report Number: 0001822565-2022-01720
• Device Sequence Number: 20224530
• Product Code: MOZ
• UDI-Device Identifier: 04987541300911
• UDI-Public: (01)04987541300911(17)231107(10)0021J07G
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2023
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00111100100
• Device Lot Number: 0021J07G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 06/29/2022; 08/05/2022
• 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 Sex: Unknown