MAUDE Adverse Event Report: HYALURONATE INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Fever (1858); Pain (1994); Chills (2191); Sleep Dysfunction (2517); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 08/04/2021

Event Type  Injury  

Event Description

I received a gel injection in my left knee on wednesday, (b)(6) 2021 by dr.(b)(6).I was instructed not to strain the knee for 48 hours and i did not do much.At that point, i had some redness and tenderness, however i was not alarmed.In a couple more days, i had more swelling and was starting to have moderate pain on the medial side of my left knee.I called dr.(b)(6) office on thursday, (b)(6) to report that i was having pain that kept me awake at night and significant swelling with redness and heat at the site.I was asked to take pictures with my phone and email to dr.(b)(6) office.I found it really hard to get pictures to do it justice, however i complied.When the office called me back, they told me that the dr.Was "confidant" that there was no infection but to keep the site clean.The pain increased over the next few days and i began having fever and chills, so i called dr.(b)(6) office as soon as it opened again on monday, (b)(6).I was told that "if i felt i needed to be seen," they would transfer my call to the appointment line however i would not be seen that day.I was really in distress by this time so i managed to get in to see my family doctor.I was diagnosed with acute erythema nodosum and treated with an iv of rocephin and solumedrol.The next day i began an oral course of medrol and keflex.While i am much improved, i still have mild to moderate pain and redness.There are also still painful nodules in my knee.Some of this had subsided but recurred when i finished my medications.I did have a vascular study on (b)(6) to rule out blood clots and it was negative.

• Brand Name: HYALURONATE INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 12407457
• MDR Text Key: 269766505
• Report Number: MW5103659
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 08/28/2021

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 72