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

Catalog Number 6301182010

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 08/04/2020

Event Type  Injury  

Event Description

Progressive debilitating left knee swelling [joint swelling].Progressive debilitating left knee pain [arthralgia].Progressive debilitating left knee persistent effusion [joint effusion].Case narrative: case (b)(4) is a serious spontaneous case received from a health professional via regulatory authority in united states.This report concerns a patient of unknown age or gender who experienced progressive debilitating left knee swelling, progressive debilitating left knee pain and progressive debilitating left knee persistent effusion during treatment with euflexxa (sodium hyaluronate) solution for injection intra-articularly, unknown concentration, for unknown indication from 2020 to an unknown stop date.A health professional reported that the patient experienced progressive debilitating left knee swelling, pain, and persistent effusion beginning one week after injection with euflexxa in 2020.The patient had multiple joint aspirations.Synovial biopsy cultures were all negative (bacterial, fungal and mycobacterial) and negative broad range pcr testing.No other information was provided.The events progressive debilitating left knee swelling, left knee persistent effusion and left knee pain were medically significant.Action taken with euflexxa was unknown.At the time of reporting, the outcome of progressive debilitating left knee swelling, pain and persistent effusion was unknown.The patient's med hist/procedure was significant for multiple joint aspirations (from unknown start date to unknown stop date) and synovial biopsy (from unknown start date to unknown stop date).No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Sender comment: important information related to drug administration has not been reported, making difficult to assess temporal casual relationship.Furthermore, indication has not been reported.Overall listedness (core label) is listed.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = mw5099881.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: 16235698
• MDR Text Key: 308041564
• Report Number: 0002244564-2021-00030
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• 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 Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability