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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Ambulation Difficulties (2544); Reaction to Medicinal Component of Device (4574)

Event Date 07/31/2020

Event Type  Injury  

Event Description

Has not been able to walk for almost a year [gait inability].Severe inflammatory reaction [inflammation].Case (b)(4) is a serious spontaneous case received from a physician via regulatory authority in united states.This report concerns a female patient of unknown age who had not been able to walk for almost a year and severe inflammatory reaction during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, 20mg/ml, unknown dose and frequency for an unknown indication from an unknown start date to an unknown stop date.Lot number: r13626a and expiration date: 28-mar-2021.The physician reported the patient had severe inflammatory reaction to euflexxa, a hyaluronic acid injection.It was a known side effect.However, the inflammatory reaction usually subsides with a few weeks.However, the inflammatory reaction has been permanent.The physician stated that the physician reached out to the company that manufacturers euflexxa and they said they would test the lot but the physician had not been able to get a response despite multiple inquiries.The patient had multiple joint aspirations and cortisone injection, which did not improve her symptoms.The patient tried arthroscopic knee surgery, which did not improve her symptoms.All infectious markers and cultures had been negative.The patient was seeing a rheumatologist, treating for an inflammatory condition.However, she had made little progress.The patient had not been able to walk for almost an year now and she would likely need a left knee replacement and right toe fusion, but she would likely have lifelong disability from this issue.Action taken with euflexxa was unknown.At the time of this report, the outcome of has not been able to walk for almost a year was not recovered, the outcome of severe inflammatory reaction was not recovered.The patient's med hist/procedure was significant for infectious markers and cultures (from unknown start date to unknown stop date) and multiple joint aspirations (from unknown start date to unknown stop date) and arthroscopic knee surgery (from unknown start date to unknown stop date).No concomitant medication was reported.The event has not been able to walk for almost a year was reported as serious.The event severe inflammatory reaction was reported as non-serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = mw5101620.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.

Event Description

1524: device appears to trigger rejection 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.Additional information was received on 03-nov-2022 from a pharmacist, follow up 01: new events of positive test for a fungal infection at the injection site and infection was due to a contaminate that was found in injectables were reported.

• 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; pob 571; parsippany 07054
• Manufacturer Contact: pob 571, be'er tuvia industria; l zone; kiryat malachi, NJ 83104-02 ; 9737961600
• MDR Report Key: 12149277
• MDR Text Key: 261224419
• Report Number: 3000164186-2021-00026
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: 6301182010
• Device Lot Number: R13626A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Sex: Female