MAUDE Adverse Event Report: EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Event Description

Hypertension, blood pressure of 175/100 [hypertension] 30 minutes after the injection, i developed chest pain [chest pain] feeling of impending doom [anxiety] extreextreme foot pain [pain in extremity] headaches, extreme "ha" [headache] my second injection was via a blood vessel in my knee [wrong technique in device usage process] case narrative: this is a serious spontaneous case received from a consumer in the united states.This report concerns a patient (unknown age and gender) who experienced hypertension/blood pressure of 175/100, 30 minutes after the injection, developed chest pain, feeling of impending doom, extreme foot pain, headaches/extreme "ha", and second injection was via a blood vessel in the patient's knee [wrong technique in device usage process], during treatment with euflexxa (sodium hyaluronate) solution for injection 1%, 2 doses, unknown route, for an unknown indication from an unknown start date to an unknown stop date.The patient reported that euflexxa would work well if injected correctly, but if not, it could be deadly.The patient stated the first injection worked great but not the second.The second injection was via a blood vessel in the patient's knee and 30 minutes after the injection, the patient developed chest pain, headaches, extreme foot pain and feeling of impending doom.The orthopedic medical doctor (md) that administered the injection was unable to come to the phone, so after several hours of worsening symptoms, the patient presented to the emergency room (er) with chest pain, extreme "ha", and a blood pressure (bp) of 175/100.The patient did not currently already have a diagnosis of hypertension.The patient reported an extremely difficult five hours in the er and was discharged and started on antihypertensive medications.The patient stated would not be taking euflexxa again and does not want to be contacted.The hypertension, blood pressure of 175/100 was medically significant.The headaches, extreme "ha" was medically significant.The extreme foot pain was medically significant.The 30 minutes after the injection, developed chest pain was medically significant.The feeling of impending doom was medically significant.Action taken with euflexxa was dose withdrawn.At the time of this report, the outcome of hypertension/blood pressure of 175/100, 30 minutes after the injection, the patient developed chest pain, feeling of impending doom, extreme foot pain, headaches/extreme "ha", and second injection was via a blood vessel in the patient's knee [wrong technique in device usage process], was unknown.No concomitant medication was reported.The events 30 minutes after the injection, developed chest pain, hypertension/blood pressure of 175/100, headaches, extreme "ha", extreme foot pain, feeling of impending doom, were reported as serious.The event second injection was via a blood vessel in the patient's knee [wrong technique in device usage process], was as non-serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related for "hypertension" and "wrong injection technique" company causality: not related for rest of reported events.Sender comment: very limited and important information has not been reported for this case including user of the md, patient's mh, laboratory findings, concomitant med., product indication, administration dates, as well as the details relating to the administration process preventing a proper medical assessment.Based on the known safety profile, when used according to label, it is considered highly likely that reported event "hypertension" and "wrong injection technique" are related to euflexxa.Company causality related.Other case numbers: internal # - others = fmc-event-000680.Internal # - others = fmc-case-003012.E2b company number = us-ferring-2023fe02066.Mw 3500a mfr.Rpt.# = 3000164186-2023-00016.Internal # - complaint = ferr7920.Internal # - complaint = fmc-event-000681.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.Case correction performed 08-may-2023: amended events chest pain, feeling of impending doom, extreme foot pain, headaches, extreme "ha" as medically significant.Removed the complaint classification in narrative, general tab, and qr227680 from the references.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• MDR Report Key: 16894857
• MDR Text Key: 314819445
• Report Number: 0002244564-2023-00020
• 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: 05/09/2023

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
• Distributor Facility Aware Date: 04/27/2023
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention