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

Model Number 89130-4444-01

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

It was considered that events were probably related to supartz fx because these events recurred 3 times after the injections.The reported adverse event was not listed in the package insert and concerned lot number was not available.

Event Description

On (b)(6) 2020 - a female patient, who used to get euflexxa injections without issue, received supartz fx injections bilaterally for osteoarthritis.On (b)(6) 2020 - she 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.She said she was worried she might have to go to the er, but finally her symptoms started to normalize.She stated she is an insulin dependent, type 1 diabetic, so it's very worrisome for her.On (b)(6) 2020 - she 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.She said she experienced the reaction within a day or two after the injection for the first 3 weeks.She said she is due for her 4th injection tomorrow but will not be getting it.

Event Description

(b)(6) 2020: a female patient, who used to get euflexxa injections without issue, received supartz fx injections bilaterally for osteoarthritis.(b)(6) 2020: she 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.She said she was worried she might have to go to the er, but finally her symptoms started to normalize.She stated she is an insulin dependent, type 1 diabetic, so it's very worrisome for her.(b)(6) 2020: she 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.She said she experienced the reaction within a day or two after the injection for the first 3 weeks.She said she is due for her 4th injection tomorrow but will not be getting it.

Manufacturer Narrative

It was considered that events were probably related to supartz fx because these events recurred 3 times after the injections.We selected the code of 4316 (appropriate term/code not available) for h.6 manufacturer evaluation conclusion code because the reported adverse event was not listed in the package insert and concerned lot number was not available.Follow-up to reporter on (b)(6), (b)(6), and (b)(6) are unsuccessed.No additional information is expected.

• Brand Name: SUPARTZ FX
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0 005; JA 100-0005
• MDR Report Key: 10832874
• MDR Text Key: 217667012
• Report Number: 9612392-2020-00011
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P980044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 89130-4444-01
• Device Catalogue Number: 7156-4444
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other