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 Chest Pain (1776); Dyspnea (1816); Inflammation (1932)

Event Date 06/29/2018

Event Type  Injury  

Event Description

Pericarditis [pericarditis].Case (b)(4) is a serious spontaneous case received from a consumer via a regulatory authority in the united states.This report concerns a female of unknown age who developed pericarditis during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, 2 ml, weekly for 3 weeks, for osteoarthritis from 2016 to an unknown stop date.The patient reported she was hospitalized and treated for pericarditis.No additional information was reported.The patient was hospitalized on (b)(6) 2018 due to pericarditis.The pericarditis was medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of pericarditis was unknown.The following concomitant medications were reported: aspirin, climara, colchicine, indocin, nasacort, women's daily formula and xyzal.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: unassessable.Other case numbers: case number, others = mw5078345.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 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; 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: 7726638
• MDR Text Key: 115242133
• Report Number: 3000164186-2018-00021
• 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: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/04/2018
• Device Catalogue Number: 6301182010
• Device Lot Number: N10839C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ASPIRIN; CLIMARA (ESTRADIOL); COLCHICINE (COLCHICINE); INDOCIN; NASACORT; WOMEN 'S DAILY FORMULA; XYZAL
• Patient Outcome(s): Hospitalization; Other