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)

Event Type  Injury  

Event Description

Physician reports patient's joints have isolated a fungus called paecilomyces [fungal infection] in 2022, patient was having inflammation in right mtp, it was aspirated and grew the same fungus, purpureocillium lilacinus [fungal infection].Inflammation in left knee and right mtp [arthritis].Inflammation in right mtp [arthritis].Injected with same lot in knee and ankle [off label use] [off label use of device].Case narrative: case (b)(4) is a serious, complaint, spontaneous case received from a physician in the united states.This report concerns a female of unknown age who experienced joints have isolated a fungus called paecilomyces, was injected with the same lot in knee and ankle [off label use of device] during treatment with euflexxa (sodium hyaluronate) solution for injection unknown dose, route, and frequency for unknown indication from an unknown start date to an unknown stop date.The physician reported that the patient's joints had isolated a fungus called paecilomyces.The fungus was isolated with more than one joint, the knee back in (b)(6) 2020, but now confirmed with foot.These joints were injected with the same lot (r13626a) and the physician requested that the lot be tested for paecilomyces fungus.The patient received euflexxa injection in right knee, left knee and right (metatarsophalangeal) mtp.(b)(6) 2020, and the patient developed inflammation in the left knee and right mtp.In (b)(6) 2020 one culture was drawn on the left knee and grew fungus, positive for purpureocillium lilacinus which grew from the left knee.At the time, the physician did not think it was a true infection since nine out of ten pcr tests done, none of which showed fungus again.Then, in 2022, the patient had inflammation in the right mtp, it was aspirated and grew the same fungus, purpureocillium lilacinus.Washouts, debridements, and multiple surgeries were done on both joints.The only common factor was that she received euflexxa.The physician reported the event of joints have isolated a fungus called paecilomyces was medically significant.The event of in 2022, the patient had inflammation in the right mtp, it was aspirated and grew the same fungus, purpureocillium lilacinus was medically significant.Action taken with euflexxa was unknown.At the time of reporting, the outcome was recovered (patient's joints have isolated a fungus called paecilomyces [(b)(6) 2020]) / unknown (all other events).Concomitant medication and medical history were not reported.The event of joints have isolated a fungus called paecilomyces and in 2022, patient was having inflammation in right mtp, it was aspirated and grew the same fungus, purpureocillium lilacinuswas reported as serious.All other events were reported as non-serious.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related for events of 'fungal infection' and 'arthritis'.Sender comment: company causality for events 'fungal infection' and 'arthritis' considered to be not related as per investigations conducted by gqa which concludes there was no relation between the reported contaminant and the natural flora at manufacturer's facility.No root cause identified.Gpv assessed the inflammation to be attributed to the infection process which is most likely caused during the injection process as also stated by gqa.Other case numbers: link: same patient = (b)(4).Link: same patient = (b)(4).Internal # - others = (b)(4).Internal # - affiliate = (b)(4).Internal # - complaint = (b)(4).Mw 3500a mfr.Rpt.# = 3000164186-2022-00008.Internal # - others = (b)(4).Internal # - affiliate = (b)(4).E2b company number = (b)(4).Internal # - complaint = (b)(4).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 received from a physician on 14-mar-2022, follow up 01: new events of inflammation in left knee and right mtp, and in 2022, the patient had inflammation in the right mtp, it was aspirated and grew the same fungus, purpureocillium lilacinus and inflammation in the right mtp were reported.Case fields and narrative updated accordingly.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: 16477858
• MDR Text Key: 310649353
• Report Number: 0002244564-2022-00008
• 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: 03/02/2023

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
• 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: 03/03/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female