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 Fever (1858); Unspecified Infection (1930)

Event Date 11/02/2020

Event Type  Injury  

Event Description

High fever [pyrexia].Cold [nasopharyngitis].Case (b)(4) is a serious spontaneous case received from consumer via the fda in united states.This report concerns a patient (no patient identifiers reported) who experienced high fever and cold during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, for osteoarthritis from an unknown start date to an unknown stop date.The patient reported being hospitalized with a cold and high fever on (b)(6) 2020.The patient was hospitalized on an unspecified date in 2020 due to cold and high fever.Action taken with euflexxa was unknown.At the time of this report, the outcome of high fever and cold was unknown.Concomitant medication and medical history were 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: related.Company causality: related.Other case numbers: internal # - others = mw5097907.Sender comment: despite of sodium hyaluronate's safety profile, a causal relationship between euflexxa's treatment and the event 'cold' cannot be ruled out, however, it is considered more likely that the fever is related to an infectious process, eg.A cold as reported and not to the product per se.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; bee'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
• MDR Report Key: 11217723
• MDR Text Key: 258350710
• Report Number: 3000164186-2021-00002
• 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: 01/22/2021

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: No Information
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization