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 Chronic Obstructive Pulmonary Disease (COPD) (2237); Unspecified Gastrointestinal Problem (4491)

Event Type  Injury  

Event Description

Acid reflux [gastrooesophageal reflux disease].Copd [chronic obstructive pulmonary disease].Case narrative: case (b)(4) is a serious spontaneous case received from a non health professional via regulatory authority in united states.This report concerns a patient (no identifiers reported) who experienced acid reflux and chronic obstructive pulmonary disease (copd) during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg, unknown dose and frequency for an unknown indication from an unknown start date to an unknown stop date.The non health care professional reported that the patient being hospitalized about a month ago (unknown date in (b)(6) 2021) due to having acid reflux and a moderate case of copd.The patient also had a pacemaker implanted on an unknown date on (b)(6) 2020.Action taken with euflexxa was unknown.At the time of this report, the outcome of acid reflux was unknown, the outcome of copd was unknown.The patient's med hist/procedure was significant for pacemaker implanted (from (b)(6) 2020).The following concomitant medications were reported: pantoprazole (from an unknown start date to an unknown stop date), anoro ellipta (from an unknown start date to an unknown stop date), benazepril (from an unknown start date to an unknown stop date).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: not related.Other case numbers: internal # others = mw5101078.Sender comment: due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the 'acid reflux' and the 'moderate case of copd' events as there is no clinical evidence for this.Furthermore, administration dates were not reported, making difficult to establish a temporal relationship.This ae occurred in united states 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.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• MDR Report Key: 16439023
• MDR Text Key: 310231729
• Report Number: 0002244564-2021-00023
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2023

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
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: ANORO ELLIPTA (UMECLIDINIUM BROMIDE, VILANTEROL TR; BENAZEPRIL (BENAZEPRIL),; PANTOPRAZOLE (PANTOPRAZOLE),
• Patient Outcome(s): Hospitalization