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

Catalog Number 6301182010

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Headache (1880); High Blood Pressure/ Hypertension (1908); Respiratory Distress (2045); Sleep Dysfunction (2517)

Event Date 09/17/2015

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

This serious spontaneous report was received from a consumer in united states. This report concerns a (b)(6) female who experienced shortness of breath, could not sleep, chest pain, almost fainted, high blood pressure, and terrible headaches during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, unk, weekly, for osteoarthritis (in left knee) from (b)(6) 2015. The patient reported that she received her first euflexxa injection on (b)(6) 2015. The patient reported that on (b)(6) 2015 she started having "terrible headaches", her blood pressure was between 167 and 169, which stayed up all evening and she felt like she almost fainted. The patient also reported that on the same day she had chest pain and was unable to sleep due to the headaches. The patient reported that after receiving the second injection of euflexxa on (b)(6) 2015 she continued having terrible headaches, her blood pressure was high (between 167 and 168). The patient reported she went to the emergency room on the evening of (b)(6) 2015 and was sent home the same night. The patient reported that her physician prescribed her verapamil for her high blood pressure and began taking verapamil on (b)(6) 2015. The patient reported that the verapamil "helped her a little" (blood pressure). The patient also reported that she had a ct of the head done on (b)(6) 2015 which showed that "everything was clear. " the patient reported she went to see her neurologist on (b)(6) 2016 for follow up. No additional ae information was reported. The shortness of breath was medically significant. Action taken with euflexxa was dose withdrawn. On an unknown date, the outcome of shortness of breath was not recovered, the outcome of could not sleep was recovered, the outcome of chest pain was recovered, the outcome of almost fainted was recovered, the outcome of high blood pressure was recovering/resolving, the outcome of terrible headaches was not recovered. The following concomitant medication was reported: omeprazole (from an unknown start date to an unknown stop date), vitamin d3 (from an unknown start date to an unknown stop date), multivitamin (from an unknown start date to an unknown stop date), synthroid (from an unknown start date to an unknown stop date), atenolol (from an unknown start date to an unknown stop date), baby aspirin (from an unknown start date to an unknown stop date). The following laboratory values were relevant: blood pressure systolic: 167-169 (no assessment), (b)(6) 2015 blood pressure systolic: 167-168 (no assessment), (b)(6) 2015 computerised tomogram: reported as "everything was clear", (b)(6) 2015. At the time of reporting the case outcome was not recovered. Overall listed : unlisted. Reporter causality: related. Company causality: unassessable. Other case numbers: (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: 5486494
• MDR Text Key: 39890392
• Report Number: 3000164186-2016-00002
• 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: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 01/16/2016
• Event Location: No Information
• Date Manufacturer Received: 01/18/2016
• 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 Treatment Data

Date Received: 03/08/2016 Patient Sequence Number: 1

Treatment

MULTIVITAMIN