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 Problem Death (1802)

Event Date 09/24/2018

Event Type  Death  

Event Description

Deceased [death].Case (b)(4) is a serious spontaneous case received from a non health professional via a regulatory authority in united states.This report concerns a patient of unknown age and gender who was deceased after treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection, with unknown concentration 20 mg, weekly for 3 weeks, for osteoarthritis from 2014 to 2018.It was reported that patient was deceased.No additional information was reported.The patient died on (b)(6) 2018 due to an unknown cause.Action taken with euflexxa was not applicable.At the time of this report, the outcome of deceased was fatal.Medical history was not reported.The following concomitant medications were reported: alprazolam, ambien, folic acid, inspra, losartan potassium, multi vitamin with fluoride, nitrolingual, "nortriptylin", norvasc, oxycodone, protonix, robaxin and vitamin c.All events in the case were reported as serious.At the time of reporting the case outcome was fatal.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: unassessable.Other case numbers: case number, others = mw5080621.This ae occurred in "teh" us 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 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: 8061003
• MDR Text Key: 126912672
• Report Number: 3000164186-2018-00037
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/27/2019
• Device Catalogue Number: 6301182010
• Device Lot Number: N16434A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death