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

Catalog Number 6301182010

Device Problem Use of Device Problem (1670)

Patient Problem Atrial Fibrillation (1729)

Event Type  Injury  

Event Description

A hospital stay due to a-fib [atrial fibrillation].Case narrative: this is a serious, spontaneous case received from a health professional, via regulatory agency, in the united states.This report concerns a patient (no patient identifiers) who experienced a hospital stay due to atrial fibrillation (a-fib) during treatment with intraarticular euflexxa (sodium hyaluronate) solution for injection 1%, 20mg/2 ml, 1 syringe in left knee weekly for three weeks, for an unknown indication from an unknown start date to an unknown stop date.The health professional reported the patient was hospitalized on an unknown date due to a-fib and was now taking eliquis.No further information provided.The patient was hospitalized on an unknown date due to a hospital stay due to a-fib.Action taken with euflexxa was unknown.At the time of this report, the outcome of a hospital stay due to a-fib was unknown.No concomitant medication was 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: related.Company causality: not related.Health effect clinical code: 1729: atrial fibrillation.Medical device problem code: 1670: use of device problem.Sender comment: very limited and important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication, product indication, administration dates, as well as the details relating to the patient's cardiac episode preventing a proper medical assessment.Based on the well-known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's a-fib.Company causality unrelated.Other case numbers: internal#: others = mw5115215.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 mdd (european council directive of 14 june 1993 93/42/eec concerning medical devices) / mdr (eu) (b)(4) and/or because it did not occur in an eu + efta country + tr and ni 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
• Manufacturer (Section G): FERRINGPH; 100 interpace parkway; parsippany 07054
• Manufacturer Contact: pob 571, be'er tuvia industria; l zone; kiryat malachi 83104-02 ; 2542274192
• MDR Report Key: 16536961
• MDR Text Key: 311223227
• Report Number: 3000164186-2023-00009
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization