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

Catalog Number 6301182010

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

Patient Problems Headache (1880); Nausea (1970)

Event Type  Injury  

Event Description

Trouble breathing [dyspnoea] dizziness [dizziness] hears his right knee cracking, hears it in both knees [crepitations] nausea [nausea] headache [headache] case narrative: this previously non-serious spontaneous case received from a consumer in the united states was upgraded to serious upon receipt of follow up information on 08-jan-2024.This report concerns a male of unknown age who experienced trouble breathing, dizziness, hears his right knee cracking, hears it in both knees, nausea and headache during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, and route, 1 injection weekly for three weeks, used for unknown indication from (b)(6) 2023 and ongoing.The patient reported that he was not feeling right and experienced trouble breathing, dizziness, hears his right knee cracking sound when walking- especially at night, after taking two injections - hears it in both knees, nausea, and headache.He was concerned about the side effects getting worse and the duration of their persistence.He was apprehensive about getting the rest of his scheduled injections due to the side effects he was experiencing.The dyspnea, dizziness, crepitations, nausea and headache was medically significant.Action taken with euflexxa was dose not changed.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Sender comment: due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for events of dyspnea, dizziness and crepitations.Overall listedness (core label) is unlisted.Reporter causality: related company causality: not related other case numbers: internal # - others = fmc-event-001765.Internal # - others = fmc-case-(b)(6).Internal # - others = mw5149339 additional information received 08-jan-2024: case has been updated from non-serious to serious.The seriousness criteria of medically significant has been added to the following events: dyspnea, dizziness, crepitations, nausea and headache.Case narrative update accordingly.This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.If applicable (i.E.For distributed us cases) add the following at the bottom of the narrative: 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 mdd (european council directive of 14 june 1993 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.Correction 17-jan-2024: occupation of reporter has been updated from patient to non-healthcare professional.

• 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: 18524471
• MDR Text Key: 332980821
• Report Number: 0002244564-2024-00006
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male