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 Death (1802); Respiratory Arrest (4461)

Event Date 01/05/2021

Event Type  Death  

Event Description

Ceased to breathe [respiratory arrest].Case (b)(4) is a serious spontaneous case received from a consumer via regulatory authority in united states.This report concerns a patient (no identifiers reported) who ceased to breathe and passed away during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg, unknown dose and frequency for bilateral primary osteoarthritis of knee from an unknown start date to an unknown stop date.The patient's mother reported that the patient ceased to breathe and passed away on (b)(6) 2016 action taken with euflexxa was not applicable.On (b)(6) 2021, the outcome of ceased to breath was fatal.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was fatal.Sender comment: based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's death, furthemore, important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication as well as the details relating to the death of the patient preventing a proper medical assessment.Overall listedness (core label) is unlisted.Reporter causality: related company causality: not related other case numbers: internal # - others = mw5098808.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.; 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: 11285668
• MDR Text Key: 230485230
• Report Number: 3000164186-2021-00004
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death