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 Problem Complaint, Ill-Defined (2331)

Event Date 06/12/2018

Event Type  Injury  

Event Description

Stomach ailment [gastric disorder].Case (b)(4) is a serious, spontaneous case received from a non health professional via a regulatory authority in the united states.This report concerns a patient of unknown age and gender who experienced a stomach ailment during treatment with euflexxa (sodium hyaluronate) solution for injection, unknown concentration, unknown dose and route of administration, for an unknown indication from an unknown start date to an unknown stop date.It as reported that on (b)(6) 2018 the patient was hospitalized for an unknown stomach ailment and does not know how long the hospitalization will be.The issue was not related to the medicine.Arxwo has not yet filled this medication for the patient.The patient was hospitalized on an unknown date due to stomach ailment.Action taken with euflexxa was unknown.At the time of this report, the outcome of stomach ailment was unknown.Concomitant medication was not reported.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: not related.Company causality: not related.Other case numbers: case number, others = mw5077974.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: 8053612
• MDR Text Key: 126643349
• Report Number: 3000164186-2018-00035
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• 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
• Date Manufacturer Received: 10/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization