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

Catalog Number 6301182010

Device Problem Off-Label Use (1494)

Patient Problem Death (1802)

Event Date 02/26/2019

Event Type  Death  

Event Description

Patient passed away [death].Bilateral primary osteoporosis of knee (off label use) [off label use of device].Drug use for unapproved indication [device use issue].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 of unknown age and gender who had passed away during treatment with euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, unknown dose and route of administration, for bilateral primary osteoporosis of knee (off label use of device [device use for unapproved indication]) from an unknown start date to an unknown stop date and the co-suspect drug synvisc one (hylan g-f 20) for an unknown indication on unknown dates.On (b)(6) 2019, the patient passed away.The reason for patient death was not reported.Action taken with euflexxa was not applicable.At the time of this report, the outcome of off label use of device and device use for unapproved indication were unknown.No concomitant medication was reported.At the time of reporting the case outcome was fatal.Overall listedness (core label) is unlisted.Reporter causality: not provided.Company causality: not related.Other case numbers: internal # - others = mw5088228.

• 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: 8934670
• MDR Text Key: 155644324
• Report Number: 3000164186-2019-00035
• 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: 08/26/2019

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 Expiration Date: 02/24/2020
• Device Catalogue Number: 6301182010
• Device Lot Number: P13138A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/27/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death