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 Diarrhea (1811); Dyspnea (1816); Nasal Obstruction (2466); Insufficient Information (4580)

Event Date 01/23/2024

Event Type  Injury  

Event Description

At times difficulty breathing [dyspnoea] euflexxa reaction [drug hypersensitivity] severely dry right palm on skin of hand with several tiny tears [dry skin] severely dry right palm on skin of hand with several tiny tears [skin laceration] runny nose and congestion [rhinorrhoea] runny nose and congestion [nasal congestion] diarrhea [diarrhoea].Case narrative: this is a serious spontaneous case received from a non-health care professional via regulatory authority in the united states.This report concerns a patient of unknown age and gender who experienced difficulty breathing at times, severely dry right palm on skin of hand with several tiny tears, runny nose, congestion and diarrhea during treatment with intraarticular use euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose and frequency for an unknown indication from an unknown start date to an unknown stop date.On (b)(6) 2024, the patient experienced a reaction to euflexxa, characterized by severe dryness on the skin of the right palm with several tiny tears, accompanied by a runny nose and congestion.The patient also reported difficulty breathing at times and diarrhea following a euflexxa knee injection.The events of difficulty breathing at times, severely dry right palm on skin of hand with several tiny tears, runny nose, congestion and diarrhea were considered serious due to disability.Action taken with euflexxa 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 listed (core label) is unlisted.Reporter causality: related company causality: related other case numbers: internal # - others = mw5151997 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) 2017/745 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
• MDR Report Key: 18985662
• MDR Text Key: 338690498
• Report Number: 0002244564-2024-00018
• 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: 03/27/2024

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 the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2024
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability