MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problems Patient Device Interaction Problem (4001); Lack of Effect (4065)

Patient Problems Local Reaction (2035); Swelling/ Edema (4577)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Pseudo­sepsis reaction and swelling [pseudosepsis].Case narrative: this is a serious spontaneous case received from a physician's assistant (who is also a consumer), via a sales representative in united states.This report concerns a male of unknown age who experienced a pseudo­sepsis reaction including swelling during treatment with euflexxa (sodium hyaluronate) solution for injection, unknown route, concentration, and dose, for an unknown indication from (b)(6) 2021 to an unknown stop date.The patient reported that he was given a euflexxa injection in (b)(6) 2021 and the second injection the following week (date not provided) which were not ultrasound guided.He stated that he developed a pseudosepsis reaction and had 60 ccs of fluid drained due to swelling on day two, another 60 ccs on day three following the second injection and was on crutches for a few days.He stated that he had received multiple courses of euflexxa (dates not provided) previously with therapeutic relief and had not had this response.The pseudo­sepsis reaction was medically significant.Action taken with euflexxa was unknown.No concomitant medication was reported.The event pseudo­sepsis reaction was reported as serious.At the time of reporting the case outcome was unknown.Sender comment: the contribution of euflexxa to pseudosepsis reaction could not be excluded due to a reasonable time relationship to drug administration.The indication of use for euflexxa and the administration of the recent dose of the drug not being guided by ultrasound (compared to previous uneventful doses) are possible confounders that could provide explanations to the event.Overall listedness (core label) is unlisted.Reporter causality: related company causality: related other case numbers: internal # - others = (b)(4).This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the medical device directive/ because it did not occur in a eu + efta country and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• MDR Report Key: 16551697
• MDR Text Key: 311380852
• Report Number: 0002244564-2022-00031
• 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: Distributor
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male