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

Catalog Number 6301182010

Device Problem Use of Device Problem (1670)

Patient Problems Inflammation (1932); Pain (1994)

Event Type  Injury  

Event Description

Bladder inflammation, pressure [cystitis noninfective].Kidney inflammation, pressure [urinary tract inflammation].Hip replacement [hip arthroplasty].Required hospitalization to relieve pressure and stones [nephrolithiasis].Chronic regional pain syndrome [pain].Case narrative: case (b)(6) 2017 is a serious spontaneous case received from a non health professional via a regulatory authority in united states.This report concerns a patient (no patient identifiers provided) who experienced bladder inflammation/pressure, kidney inflammation/pressure, hip replacement, required hospitalization to relieve pressure and stones and chronic regional pain syndrome during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown dose and frequency, used for unknown indication from an unknown start date to an unknown stop date and co-suspect drug covid-19 vaccine mrna (pfizer), 2 doses, for immunisation from an unknown start date to an unknown stop date.The consumer reported that the patient had a second hip replacement, was diagnosed with chronic regional pain syndrome (crps), had bladder and kidney inflammation after both covid-19 vaccines (pfizer) and first required hospitalization to relieve pressure and stones.No further information was provided.The patient was hospitalized on an unknown date due to bladder inflammation/pressure.The patient was hospitalized on an unknown date due to kidney inflammation/pressure.The patient was hospitalized on an unknown date due to hip replacement.The patient was hospitalized on an unknown date due to required hospitalization to relieve pressure and stones.Action taken with euflexxa was unknown.Action taken with covid-19 vaccine mrna was unknown.At the time of reporting, the outcome of bladder inflammation/pressure was unknown, the outcome of kidney inflammation/pressure was unknown, the outcome of hip replacement was unknown, the outcome of required hospitalization to relieve pressure and stones was unknown, the outcome of chronic regional pain syndrome was unknown.The patient's med hist/procedure was significant for hip replacement (from unknown start date to unknown stop date).No concomitant medication was reported.The events bladder inflammation, pressure, kidney inflammation, pressure, hip replacement, required hospitalization to relieve pressure and stones were reported as serious.The event chronic regional pain syndrome was reported as non-serious.At the time of reporting the case outcome was unknown.Sender comment: due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the 'bladder inflammation/pressure', 'kidney inflammation/pressure' and 'hip replacement' events as there is no clinical evidence, furthermore, it was reported that the bladder and kidney inflammation developed after covid vaccine, and the crps after the hip replacement.Overall listedness (core label) is unlisted.Reporter causality: not related.Company causality: not related.Other case numbers: mw5105059.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.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• MDR Report Key: 16477853
• MDR Text Key: 310696582
• Report Number: 0002244564-2021-00050
• 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: Other
• Type of Report: Initial
• Report Date: 03/01/2023

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
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization