MAUDE Adverse Event Report: MEIJI PHARMA SPAIN HYALGAN (SODIUM HYALURONATE) OR DERIVATIVE, TRIVISC; ACID, HYALURONIC, INTRAARTICULAR

Patient Problems Muscle Weakness (1967); Pain (1994)

Event Date 09/28/2023

Event Type  Injury  

Event Description

"'how are your arms?" these are the words spoken to me prior to the receipt of my 2nd, as well as my 3rd, gel injections to both of my knees.No other practice had ever asked such a question ¿ before/during/after.Oddly enough, some 2/3 weeks after my 3rd injection, i realized why this question was being asked ¿ twice.I suddenly woke up with excruciating pain in both of my arms and also in both of my shoulders.My strength had greatly demolished.I was barely able to lift my arms to even shoulder length.It is now some 4 months later.And i am about 60% to where i was prior to these injections.My former strength is around 40%.Rothman orthopedics claimed that my situation had nothing to do with the gel.My brand new primary new primary doctor agreed.However, i am in that category of the 1! of all of the bad things shown on tv happening/may happen to some people, ¿check with your doctor¿ doesn¿t work, as no one but myself knows my body better than myself.¿how are your arms?¿ when i asked, twice, why it was being asked of me, i was told, ¿oh, we¿re just checking on your general health.¿ so, all of my previous orthopedic doctors (4) did not care about my general health? shouldn¿t my knee health come first? where, exactly , were those 6shots placed into my body? arms/knees? doctor clair did try to have me replace both of my knees.I¿m 86¿.

• Brand Name: HYALGAN (SODIUM HYALURONATE) OR DERIVATIVE, TRIVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): MEIJI PHARMA SPAIN
• MDR Report Key: 18630193
• MDR Text Key: 334614712
• Report Number: MW5150988
• 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: 01/22/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2024
• Patient Sequence Number: 1
• Treatment: A 2400 MCG.; ALPHA LIPOLIC ACID.; B6 100 MG.; BAYER ASPIRIN 81 MG.; CURCUMIN.; FISH OIL 1200 MG.; FOOD CAROTENE 7,500 MCG.; GARLIC EXTRACT 1000 MG.; GINGER ROOT 550 MG.; GINKGOLD 60 MG.; GINSENG 1500MG.; GREEN TEA 315 MG.; LISINOPRIL 20MG 1 DAILY.; MAITAKE 550 MG.; MULTIVITAMINS.; OSTEO BI-FLEX 3.; PHOSPHATIDYL SERINE 150 MG.; POTASSIUM 90 MG. ; QUERCETIN COMPLEX.; ROSUVASTATIN 5 MG 1 DAILY ( JUST STOPPED TAKING IT).
• Patient Outcome(s): Disability
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White