MAUDE Adverse Event Report: SEIKAGAKU CORPORATION, TAKAHAGI PLANT SUPARTZ FX; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Fatigue (1849); Hyperglycemia (1905); Hypersensitivity/Allergic reaction (1907); Polydipsia (2604); Unspecified Gastrointestinal Problem (4491)

Event Date 09/03/2020

Event Type  Injury  

Event Description

Patient called to report an adverse reaction to supartz fx.Patient stated she use to get euflexxa injections for her osteoarthritis and never had an issue.Patient said due to insurance, she started getting bilateral supartz fx injections on (b)(6) 2020, one week apart for 5 weeks.Patient said within a day or two after receiving her first injection, she had high blood sugar, lower gi issues, fatigue, felt thirsty, and just felt an overall bad feeling.Patient said she was worried she might have to go to the er, but finally her symptoms started to normalize.Patient stated she is an insulin dependent, type 1 diabetic, so it's very worrisome for her.Patient said she was told by her provider that supartz fx was exactly the same as euflexxa, but it's not, it contains an egg or poultry additive which she feels may be triggering her reaction.Patient said she experienced the reaction within a day or two after the injection for the first 3 weeks.Patient said she is due for her 4th injection tomorrow but will not be getting it.

• Brand Name: SUPARTZ FX
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 10579647
• MDR Text Key: 208588564
• Report Number: MW5096838
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR