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 Stacking Breaths (1593); Erythema (1840); Fatigue (1849); Memory Loss/Impairment (1958); Skin Discoloration (2074); Lethargy (2560)

Event Date 11/27/2017

Event Type  Injury  

Event Description

Heart valve issue [cardiac valve disease].Case (b)(4) is a serious, spontaneous case received from a consumer in united states.This report concerns a (b)(6) female who experienced a heart valve issue, appeared grayish in color, had a blushed face, shallow breathing, was very sleepy, lethargic and almost could not remember where she was during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, (dose unknown)one time series, for osteoarthritis from (b)(6) 2017 and ongoing.The patient received an injection of euflexxa on (b)(6) 2017.It was reported that the patient experienced a heart valve issue (unspecified) on (b)(6) 2017.The heart valve issue was further explained that on (b)(6) 2017 the patient appeared grayish in color with a blushed face, experienced shallow breathing, was really sleepy, lethargic, and almost could not remember where she was.It was reported that the patient's daughter called the paramedics and the patient was hospitalized overnight.During her hospitalization, the patient underwent testing such as a ct scan, mri, blood work (unspecified), urine test (unspecified), and heart monitoring.It was reported that all of the tests came back negative and good.The patient's daughter reported that on (b)(6) -2017, the patient could not remember some of the things that happened because the patient slept off and on during her hospitalization.It was reported that the patient was steadier and her knee felt better.The patient was hospitalized on (b)(6) 2017 due to heart valve issue.Action taken with euflexxa was dose not changed.At the time of this report, the outcome of all of the events was recovering/resolving.The patient`s medical history was significant for hip replacement (from 2007 to 2007) and numbness in toes (from unknown start date to unknown stop date).The patient`s procedures included ct scan (from (b)(6) 2017 to (b)(6) 2017), heart monitoring (from (b)(6)2017 to (b)(6) 2017), blood work (from (b)(6) 2017 to (b)(6) 2017), and mri (from (b)(6) 2017 to (b)(6)2017).The following concomitant medications were reported: coreg, losartan, aspirin, lipitor, and antivert.Relevant laboratory values included: urine analysis: no results.Ni (negative), (b)(6) 2017.The event heart valve issue was reported as serious.At the time of reporting the case outcome was recovering/resolving.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: case number, others =(b)(4).This ae occurred in the us 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 + 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.

• 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.; pob 571, be'er tuvia industria; kiryat malachi,, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 7113475
• MDR Text Key: 94755996
• Report Number: 3000164186-2017-00035
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2017
• 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
• Treatment: ANTIVERT (MECLOZINE HYDROCHLORIDE, NICOTINIC ACID); ASPIRIN (ACETYLSALICYLIC ACID); COREG (CARVEDILOL); LIPITOR (ATORVASTATIN CALCIUM); LOSARTAN (LOSARTAN)
• Patient Outcome(s): Hospitalization
• Patient Age: 93 YR
• Patient Weight: 54