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

Catalog Number 6301182010

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

Patient Problem Pulmonary Edema (2020)

Event Date 08/25/2021

Event Type  Injury  

Event Description

Fluid in lungs [pulmonary oedema].Case (b)(4) is a serious spontaneous case received from a consumer via a regulatory authority in united states.This report concerns a patient (no patient identifiers provided) who experienced fluid in lungs during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg, unk, for product used for unknown indication from an unknown start date to an unknown stop date.The patient's wife reported that the patient was admitted to the hospital for five days for fluid in the lungs and was on amoxicillin for treatment.Event date was reported as (b)(6) 2021.The patient "had not yet filled medication" (not otherwise specified).The patient was hospitalised on an unknown date due to fluid in lungs.Action taken with euflexxa was unknown.At the time of this report, the outcome of fluid in the lungs was unknown.No concomitant medication or medical history were reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Sender comments: important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication 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 fluid in the lungs.Company causality not related.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = mw5103726.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.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 12608967
• MDR Text Key: 276104936
• Report Number: 3000164186-2021-00042
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization