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

Catalog Number 6301182010

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 08/02/2020

Event Type  Death  

Event Description

Patient passed away [death].Case (b)(6) 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 intra-articular euflexxa (sodium hyaluronate) solution for injection 10mg/ml, unknown dose, and frequency for an unknown indication from an unknown start date to an unknown stop date.On (b)(6) 2020, the patient passed away.The patient died on (b)(6) 2020 due to an unknown cause.Action taken with euflexxa was not applicable.On (b)(6) 2020, the outcome was fatal.The following concomitant medications were reported: amlodipine (from an unknown start date to an unknown stop date), atenolol (from an unknown start date to an unknown stop date), b12 [cyanocobalamin] (from an unknown start date to an unknown stop date), furosemide (from an unknown start date to an unknown stop date), magnesium (from an unknown start date to an unknown stop date), repaglinide (from an unknown start date to an unknown stop date), simvastatin (from an unknown start date to an unknown stop date), stool softener (from an unknown start date to an unknown stop date), warfarin (from an unknown start date to an unknown stop date).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: internal # - others = mw5096594.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.Ferring's sender comment: association of death with euflexxa treatment is unassessable.Further assessment if precluded by inadequate information in the report that was limited only to the occurrence of death.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; bee'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
• MDR Report Key: 10647930
• MDR Text Key: 210378904
• Report Number: 3000164186-2020-00013
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/07/2021
• Device Catalogue Number: 6301182010
• Device Lot Number: R13444A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; ATENOL; B12; DOCUSATE SODIUM; FUROSEMIDE; MAGNESIUM; REPAGLINIDE; SIMVASTATIN; WARFARIN
• Patient Outcome(s): Death