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); Hemorrhage/Bleeding (1888)

Event Type  Death  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Internal bleeding [internal haemorrhage].This serious, spontaneous report was received from a physician's assistant in united states.This report concerns a male (unknown age) who experienced internal bleeding during treatment with euflexxa (sodium hyaluronate) solution for injection of unknown dose and route of administration, for an unknown indication on unknown dates.It was reported that the patient was administered euflexxa (date unspecified) and passed away a few weeks later from internal bleeding.It was reported that the patient was also on anticoagulants (unspecified).The physician's assistant did not think the death was due to euflexxa.The patient died on an unknown date due to internal bleeding.Action taken with euflexxa was unknown.At the time of this report, the outcome of the event was fatal.Concomitant medication use was not reported.At the time of reporting the case outcome was fatal.Overall listedness (core label) is unlisted.Reporter causality: not related company causality: not related other case numbers: case number, others = (b)(4).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 + (b)(6) country and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.(b)(4).

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 6621408
• MDR Text Key: 76956564
• Report Number: 3000164186-2017-00010
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 05/11/2017

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: Health Professional
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death