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

Catalog Number	6301182010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Arthralgia (2355); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Infection on the right knee after administration of euflexxa second dose [injection site infection] hot to touch [knee] [joint warmth] increased pain [knee] [arthralgia] swelling [knee] [joint swelling] case narrative: this is a serious spontaneous case received from a non-healthcare professional in united states.This report concerns a 62-year-old female patient (height: 160 cm, weight: 81 kg, bmi: 31), who experienced infection on the right knee after administration of euflexxa second dose, increased pain [knee], swelling [knee] and hot to touch [knee] during treatment with euflexxa (sodium hyaluronate) solution for injection; unknown concentration, route of administration and indication.First and second doses were administered on (b)(6) 2024 and respectively.On (b)(6) 2024, medical office staff called to report that a patient developed an infection on the right knee after administration of euflexxa second dose.First dose was administered on (b)(6) 2024 and second dose was given on (b)(6) 2024.Symptoms noted were increased pain, swelling, and knee was hot to the touch.On (b)(6) 2024, the healthcare professional did fluid aspiration and she was diagnosed with an infection; hence, the patient was sent to the emergency room.On (b)(6) 2024, the patient underwent surgery and was treated with antibiotics through a pick line with irrigation and is expected to receive it for four weeks.She was also treated with hydrocodone 7.5mg, ibuprofen 200mg, and meloxicam 15mg.It was reported that, at the time of this report, the patient still had the symptoms and would stay in the hospital until (b)(6) 2024.The event of infection on the right knee after administration of euflexxa second dose was considered serious due to hospitalization.Action taken with euflexxa was not applicable.At the time of this report, the outcome of infection on the right knee after administration of euflexxa second dose, increased pain [knee], swelling [knee] and hot to touch [knee] was not recovered.The patient's med history/procedure included surgery (performed on (b)(6) 2024) and fluid aspiration (performed on (b)(6) 2024).No concomitant medication was reported.Sender comment: important information has not been reported for this case including product indication, concomitant medication as well as the details relating to the procedure preventing a proper medical assessment.The conservative assessment of the causality was based on the limited information provided in the report.It is considered more likely that the infection is related to the administration procedure or handling of the device and not related to the product per se.The patient was previously administered with the product without any issue.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = fmc-case(b)(4).Internal # - others = fmc-event(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 mdd (b)(6) 1993 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni 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
• Common Device Name: 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; parsippany 07054
• Manufacturer Contact: pob 571, be'er tuvia industria; l zone; kiryat malachi 83104-02 ; 2542274192
• MDR Report Key: 20281553
• Report Number: 3000164186-2024-00045
• Device Sequence Number: 14327961
• Product Code: MOZ
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: PMA P010029¿
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2025
• Device Catalogue Number: 6301182010
• Device Lot Number: 030906
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 82 KG