MAUDE Adverse Event Report: SEIKAGAKU CORP., TAKAHAGI PLANT GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Autoimmune Reaction (1733); Erythema (1840); Fever (1858); Pain (1994); Rash (2033); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 08/11/2019

Event Type  Injury  

Event Description

I had gel-one injection in my right knee on (b)(6) 2019.I felt fine, injection site was slightly sore.On (b)(6), i began feeling achy (flu like).By (b)(6), i had a fever and a red rash going down my right leg.On (b)(6) i was hospitalized with a 103+ fever, the rash moving from the right leg to the abdomen, right and left buttocks and left leg to the knee.I was disoriented.Rash very very painful and spreading more each day.Spent 6 days in the hosp.Infectious disease specialists tested for all types of tick borne illnesses and those were negative.Many biopsies also."sweet syndrome" was the final diagnosis.Autoimmune reaction to the gel one injection.Zimmer biomet.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP., TAKAHAGI PLANT
• MDR Report Key: 9219694
• MDR Text Key: 164325605
• Report Number: MW5090541
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 54