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

Model Number 00-1111-001-00

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Erythema (1840); Fatigue (1849); Itching Sensation (1943); Nausea (1970); Pain (1994); Rash (2033); Vomiting (2144); Dizziness (2194); Shaking/Tremors (2515); Syncope/Fainting (4411); Swelling/ Edema (4577)

Event Date 02/28/2022

Event Type  Injury  

Event Description

(b)(6) 2022 - 10:00 am: patient received gel-one injection into the right knee for osteoarthritis.10:30 am: swelling and stiffness of the knee developed.11:30 am: severe pain and very difficult to walk developed.1:30 pm: hives, severe itching and redness of the trunk developed.Patient called the injection md but only got a machine so left a message.Patient took 50 mg of benadryl on patient's own.2:15 pm: itching subsided and swelling reduced significantly so that the knee bent and almost no pain walking.3:00 pm: md office had the returned call on the wrong phone and left a message.Patient returned the call and said everything seemed to be clearing up and that patient seemed fine.3:15 pm: while dressing after taking a shower, patient began to feel lightheaded, dizzy and nauseated so turned to sit down.Patient apparently had syncope and woke up on the floor with no apparent body injuries.Patient felt gero-like symptoms and took tums.3:30 pm: vomiting and tremors began.Patient called md and spoke directly to him.He instructed patient to call ems if patient had any dyspnea.Patient ordered medrol dosepak at local pharmacy but patient had to find someone to get it (bad delay because of high season tourism and traffic.).3:45 pm: patient noticed the voice was getting weird and hoarse upper lip was beginning to swell (patient believe the lack of oxygen had affected patient's judgement and thinking ability and should have called ems at this point.).4:30 pm: medrol dosepak arrived and patient took 3 tabs and 50 mg of benadryl.Md called again and stressed calling ems if any dyspnea.5:00 pm, symptoms were rapidly disappearing except for the weird voice.5:30 pm: patient felt almost normal.For approximately the following three weeks, patient experienced extreme fatigue to the point of eating normally but then reclining and being unable to do anything for hours until the next meal.Also patient experienced some dyspnea at times.After 3 weeks, patient began to feel normal again.

Manufacturer Narrative

This case is received by seikagaku corporation on june 2, 2022 via e-mail from the fda as (b)(4) dated (b)(6) 2022.

Event Description

Additional information received on (b)(6) 2022 was as follows: the patient has allergic history but never had any allergies to cinnamon or any poultry products.(see b.7.Other relevant history, including preexisting medical conditions) the patient has received concomitant drugs.

Manufacturer Narrative

This follow-up report is based on an update received by our sales partner; zimmer biomet on (b)(6) 2022, which was forwarded to us on (b)(6) 2022.The update are as follows; 1) patient's allergic history.2) concomitant drugs.This case is originally received via e-mail from the fda as mw5109568 dated june 1, 2022.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 6-1, marunouchi 1-chome; marunouchi center building; 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: 6-1, marunouchi 1-chome; marunouchi center building; chiyoda-ku, tokyo 100-0-005
• MDR Report Key: 14881209
• MDR Text Key: 295126497
• Report Number: 9612392-2022-00004
• 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
• PMA/PMN Number: P080020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2023
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Device Lot Number: 0021J07G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADVIL PM.; BENADRYL.; CALTRATE WITH D.; CLARITIN.; ESTRADIOL VAGINAL CREAM 1%.; FLONASE NASAL SPRAY.; VITAMIN D3.
• Patient Outcome(s): Other