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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Fever (1858); High Blood Pressure/ Hypertension (1908); Pain (1994)

Event Date 04/23/2016

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Knee pain [arthralgia], breathing problem [dyspnoea], dengue [dengue fever], blood pressure abnormal [blood pressure abnormal].This serious spontaneous report was received from a consumer in (b)(6).This report concerns a (b)(6) female who experienced knee pain, breathing problem, dengue and blood pressure abnormal during treatment with euflexxa (sodium hyaluronate) solution for injection 1 %, for dysarthria from (b)(6) 2016 to an unknown stop date.On an unknown date, the patient experienced blood pressure abnormal.In (b)(6) 2016, the patient experienced dengue.On (b)(6) 2016, the patient experienced knee pain.On (b)(6) 2016, the patient experienced breathing problem.The patient was hospitalised on an unknown date due to breathing problem.And knee pain.It was unknown how long the patient remained hospitalized and, additional information regarding investigations and status of treatment was not provided.Action taken to euflexxa was unknown.On an unknown date, the outcome of dengue and blood pressure abnormal were recovered, the outcome of knee pain and breathing problem were not recovered.The patient`s medical history included dietary control, tobacco user, osteoporosis and hypertension.There was not reported any concomitant medication.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: (b)(4).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 + efta country and did not result in a corrective action by the manufacturer.

• 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: 5689050
• MDR Text Key: 46257991
• Report Number: 3000164186-2016-00009
• 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: consumer
• Type of Report: Initial
• Report Date: 05/12/2016

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
• Distributor Facility Aware Date: 01/16/2016
• Initial Date Manufacturer Received: 05/12/2016
• Initial Date FDA Received: 05/31/2016
• 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): Hospitalization
• Patient Age: 77 YR
• Patient Weight: 60