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

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); Rash (2033); Vomiting (2144); Dizziness (2194); Shaking/Tremors (2515); Syncope/Fainting (4411); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/28/2022

Event Type  Injury  

Event Description

Required medral pak.In 2016, i had a mild adverse reaction to syn vise that was injected into my left knee.Hours after the injection, my knee began to swell and i elevated it and used ice packs.The next day.I was unable to bend the knee at all and notified the physician: who wanted to see me asap.At the appointment, he withdrew 15-20 ccs of fluid, (i cannot remember the exact amount because of the time that has elapsed) and reprimanded me for not reporting the reaction the day before.I know the physician quite well so i was not upset with him.(as a side note, i am a retired rn with an ms in education.I taught nursing for 13 years in a college and later was director of education in a 300 bed (b)(6) hospital so should have been more responsive.I am stating this because without a doubt this affected my response to the following event.) by the next day, the size of the knee was close to normal and eventually returned to pre syn visc size.Later that year.I had to have a total knee arthroplasty.Now it is 9 yrs later and my right knee is very osteoarthritis.Because i am now alone, i wanted to avoid surgery if at all possible.After speaking with my orthopedist and another orthopedist from (b)(6) and sharing my reaction to syn visc 9 yrs ago, i was rather assured that gel one was a newer gel and very safe.Both physicians said they had never had any reaction to gel one so i felt safe and agreed to the procedure.On (b)(6) at 10 am, gel one was injected into my right knee.After leaving the dr.'s office and within 30 minutes, the knee began to swell.Within the first hour of the injection, more of the leg was swollen, i was unable to bend the knee and it became very painful to walk.Now this is where i must interject that my apparent arrogance of being an rn interfered with my judgement."i knew how to treat this i thought".In the md's defense, i did not notify him at this point.Now i will remove the drama and just give the facts.At 10:00 am: injection of gel one; 10:30 am: swelling and stiffness of the knee; 11:30 am: pain severe and very difficult to walk; 1:30 pm: hives, severe itching and redness of the trunk; called md but only got a machine so left a message, i took 50 mg of benadryl on my own.2:15 pm: itching subsided, 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.I returned the call and said everything seemed to be clearing up and that i seemed fine.At 3:15 pm: while dressing after taking a shower, i began to feel lightheaded, dizzy and nauseated so turned to sit down.Apparently had syncope and woke up on the floor with no apparent body injuries.Felt gero-like symptoms and took tums.At 3:30 pm: vomiting and tremors began, called md and spoke directly to him.He instructed me to call ems if i had any dyspnea.Ordered medrol dose pak at local pharmacy but i had to find someone to get it (bad delay because of high season tourism and traffic.) at 3:45 pm: noticed my voice was getting weird and hoarse upper lip was beginning to swell (i believe the lack of oxygen had affected my judgement and thinking ability and should have called ems at this point.) at 4:30 pm: medral pak arrived, took 3 tabs and 50 mg of benadryl.Md called again and stressed calling ems if any dyspnea.At 5:00 pm, symptoms were rapidly disappearing except for the weird voice.At 5:30 pm: felt almost normal and was hungry so friend fixed dinner and i ate a normal amount and felt good.Went to bed later but due to the amount of steroids i had taken i was unable to sleep.At 2:00 am: everything back to normal but unable to sleep more than 3 hours.For approx.The following three weeks, i 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 experienced some dyspnea at times.After 3 weeks, i began to feel normal again.

• Brand Name: GEL ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 14311819
• MDR Text Key: 291228949
• Report Number: MW5109568
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Treatment: ADVIL 400 MG PRN ; BUDESONIDE 3 MG 84 DAYS (WEANING OFF); CALTRATE 600+D ; VIT D3 25 MCG
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White