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

Catalog Number 6301182010

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problems Inflammation (1932); Fungal Infection (2419); Ambulation Difficulties (2544)

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].Positive test for a fungal infection at the injection site [fungal infection].Infection is due to a contaminant that is found in injectables [exposure via contaminated device].Case narrative: this is a serious spontaneous complaint 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, severe inflammatory reaction to euflexxa, positive test for a fungal infection at the injection site, and infection was due to a contaminate that was found in injectables 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 reporter stated that the patient had a severe inflammatory reaction to euflexxa, a hyaluronic acid injection which was a known possible side effect.However, the reporter explained that inflammatory reactions usually subside with a few weeks; however, the patient's inflammatory reaction had been permanent.The patient had multiple joint aspirations and cortisone injections which did not improve her symptoms.The patient also tried arthroscopic knee surgery, which did not improve her symptoms either.All infectious markers and cultures had been negative.The patient was seeing a rheumatologist, who was treating the patient 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.The pharmacist reported on (b)(6) 2022 that the patient had a positive test for a fungal infection at the injection site and was still unable to walk as her knee was completely destroyed.The infection was due to a contaminate that was found in injectables.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 outcome of positive test for a fungal infection at the injection site was not recovered and the outcome of infection was due to a contaminate that was found in injectables was unknown.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 events has not been able to walk for almost a year and severe inflammatory reaction were reported as serious.The events positive test for a fungal infection at the injection site and infection was due to a contaminate that was found in injectables were non-serious.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # others = mw5101620.Mw 3500a mfr.Rpt.# = 3000164186-2021-00026.E2b company number = (b)(4).Internal # complaint = (b)(4).Internal # others = (b)(4).Internal # others = 3000164186-2022-00008/ internal # complaint = (b)(4).Health effect - clinical code(s): 1932: inflammation.2544: ambulation difficulties.Medical device problem code(s): 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
• MDR Report Key: 16439029
• MDR Text Key: 310234133
• Report Number: 0002244564-2021-00026
• 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: Physician
• Type of Report: Initial
• Report Date: 02/24/2023

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 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
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization
• Patient Sex: Female