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

Model Number 00-1111-001-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Erythema (1840); Fatigue (1849); Itching Sensation (1943); Nausea (1970); Pain (1994); Vomiting (2144); Dizziness (2194); Shaking/Tremors (2515); Ambulation Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/28/2022

Event Type  Injury  

Event 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 Description

No additional event information is available at the time of this report.

Event 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
• Type of Device: BIOLOGICS
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 6-1, marunouchi; 1-chrome chiyoda-ku, tokyo
• MDR Report Key: 14717908
• MDR Text Key: 294903883
• Report Number: 0001822565-2022-01720
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 04987541300911
• UDI-Public: (01)04987541300911(17)231107(10)0021J07G
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other