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

Catalog Number 6301182010

Device Problem Use of Device Problem (1670)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Type  Injury  

Event Description

Chf [cardiac failure congestive].Case narrative: (b)(6) is a serious spontaneous case received from a health professional via regulatory authority in the united states.This report concerns a female patient of unknown age who experienced congestive heart failure (chf) during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, 1 syringe intra-articular into the right knee for 3 weeks, for unknown indication from an unknown start date to an unknown stop date.The reporter stated that the patient's daughter said that her mother was currently in the hospital due to congestive heart failure (chf).The patient was hospitalized on an unspecified date 2022 due to chf.Action taken with euflexxa was unknown.At the time of the report,, the outcome of chf was not recovered.No concomitant medication was reported.All events in the case were reported as serious.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = mw5108905.4446: heart failure/congestive heart failure 2993: adverse event without identified device or use problem 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: 16551693
• MDR Text Key: 311385618
• Report Number: 0002244564-2022-00023
• 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: 03/15/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female