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 Malaise (2359); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/01/2021

Event Type  Death  

Event Description

Patient passed away [death].Heart failure [cardiac failure].Lots of complications [unevaluable event].Not feeling well [malaise].Case (b)(4) is a serious spontaneous case received from a health professional via a regulatory authority in united states.This report concerns a male of unknown age who was not feeling well, had lots of complications, heart failure and patient passed away, during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose and frequency, for unknown indication from an unknown start date to an unknown stop date.The patient's wife reported to the pharmacy that the patient passed away in (b)(6) 2021 she stated he was not feeling well, had lots of complications, and heart failure.Cause of death was not provided.It was unknown if an autopsy was performed.No additional information was provided.The patient died in (b)(6) 2021 due to unspecified reasons.Action taken with euflexxa was not applicable.On an unknown date, the outcome of patient passed away was fatal, the outcome of heart failure was unknown, the outcome of lots of complications was unknown, the outcome of not feeling well was unknown.The following concomitant medications were reported: vemlidy (from an unknown start date to an unknown stop date), tacrolimus (from an unknown start date to an unknown stop date).The events patient passed away and heart failure were reported as serious.The events lots of complications, not feeling well were reported as non-serious.At the time of reporting the case outcome was fatal.Very limited information has been reported, including the patient's medical history, laboratory findings, product indication, administration dates, as well as the details relating to the death of the patient preventing a proper medical assessment.Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's death but most likely due to also unrelated cardiac failure company causality unrelated.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related for event death and cardiac failure.Other case numbers: internal # - others = mw5103547.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.Sender comment: very limited information has been reported, including the patient's medical history, laboratory findings, product indication, administration dates, as well as the details relating to the death of the patient preventing a proper medical assessment.Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's death but most likely due to also unrelated cardiac failure company causality unrelated.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 12520446
• MDR Text Key: 273003422
• Report Number: 3000164186-2021-00038
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TACROLIMUS; VEMLIDY (TENOFOVIR ALAFENAMIDE FUMARATE)
• Patient Outcome(s): Death