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

Catalog Number 6301182010

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Death (1802)

Event Date 04/11/2019

Event Type  Death  

Event Description

Patient passed away [death].Case (b)(4) is a serious spontaneous case received from a non health professional via regulatory authority in united states.This report concerns a patient (no identifiers reported) who passed away during treatment with euflexxa (sodium hyaluronate) solution for injection 10 mg, unknown dose, for bilateral primary osteoarthritis of knee from an unknown start date to an unknown stop date.The consumer reported that the patient passed away on (b)(6) 2019.Cause of death unknown.Action taken with euflexxa was not applicable.No concomitant medication was reported.The event was reported as serious.The case outcome was fatal.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = mw5089369.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 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 ; 8443044828
• MDR Report Key: 9175330
• MDR Text Key: 161920655
• Report Number: 3000164186-2019-00044
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/24/2020
• Device Catalogue Number: 6301182010
• Device Lot Number: P13138A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death