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

Catalog Number 6301182010

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pain (1994); Arthralgia (2355)

Event Type  Injury  

Event Description

Shortness of breath [dyspnoea].Euflexxa has not helped with putting weight on her knee while going up stairs.[weight bearing difficulty].Stiffness in her right knee that also seems to affect the left leg too [joint stiffness] pain [knee] [arthralgia].Pain she had prior to euflexxa has remained the same [device ineffective].Case narrative: this is a serious spontaneous complaint case received from a consumer in the united states.This report concerns an elderly female who experienced shortness of breath, stiffness in her right knee, no help with putting weight on her knee while going up stairs, and pain [knee] she had prior to treatment remained the same during treatment [device ineffective] with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route, and frequency, used for arthritis from an unknown start date to an unknown stop date.On (b)(6) 2023, the patient reported that she took euflexxa every six months for a "couple of years" in her right knee but could not recall when her first series of injections were.The patient reported that the pain she had prior to receiving euflexxa remained the same but now had new stiffness in her right knee that also seemed to affect the left leg too.She stated that the only thing that improved with euflexxa was the "pushing the leg forward and back" while going up stairs but it had not helped with putting weight on her knee while going up stairs.The patient stated that she had arthritis in her knee and "all over".The patient also reported that she had "shortness of breath" in (b)(6) 2022 and had a pacemaker put in (b)(6) 2022.The patient reported having to start losartan for her blood pressure.The shortness of breath required an intervention (pacemaker insertion).Action taken with euflexxa was unknown.The following concomitant medication were reported: losartan (from an unknown start date to an unknown stop date), doxidan [dantron;docusate calcium] (from an unknown start date to an unknown stop date), zyrtec [cetirizine hydrochloride] (from an unknown start date to an unknown stop date).Garlic pills [allium sativum] (garlic [allium sativum]) from an unknown start date to an unknown stop date.The event shortness of breath was reported as serious.The events stiffness in her right knee that also seems to affect the left leg too, euflexxa has not helped with putting weight on her knee while going up stairs, pain she had prior to euflexxa has remained the same were reported as non-serious.At the time of reporting the outcome of the event of shortness of breath was unknown and the outcome of the events of stiffness in her right knee that also seems to affect the left leg too, not helped with putting weight on her knee while going up stairs, and pain were not recovered.Sender comment: important information has not been reported for this case including the patient's medical history, laboratory findings, administration dates, as well as the details relating to the dyspnoea of the patient preventing a proper medical assessment.Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's dyspnoea as there is no clinical evidence.Company causality unrelated.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related for event dyspnoea.Related for the other reported events.Other case numbers: (b)(4).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 (b)(6) 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
• 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: 16215566
• MDR Text Key: 307971336
• Report Number: 3000164186-2023-00005
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• 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 Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: DOXIDAN [DANTRON,DOCUSATE CALCIUM] (DANTRON, DOCUS; GARLIC [ALLIUM SATIVUM] (GARLIC [ALLIUM SATIVUM]),; LOSARTAN (LOSARTAN),; ZYRTEC [CETIRIZINE HYDROCHLORIDE] (CETIRIZINE HYDR
• Patient Outcome(s): Required Intervention
• Patient Sex: Female