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

Catalog Number 6301182010

Device Problem Use of Device Problem (1670)

Patient Problems Hypersensitivity/Allergic reaction (1907); Synovitis (2094)

Event Type  Injury  

Event Description

Synovitis [synovitis].Synovitis led to other knee problems [arthropathy].Reaction in both knees [adverse reaction].Patient requesting an investigation [device issue].Case narrative: (b)(4) is a serious spontaneous case received from a pharmacist in united states.This report concerns a 61-year old female who experienced severe synovitis, which led to other knee problems and reaction in both knees during treatment with euflexxa (sodium hyaluronate) solution for injection unknown dose, route and concentration, used for unknown indication from an unknown start date to an unknown stop date.Lot number r13626a with expiry date 28-mar-2021.A pharmacist reported that a patient reported she had a reaction in both knees that led to severe synovitis which led to other knee problems (unspecified).Euflexxa was filled in (b)(6) 2020, however, dates of injection(s) were unknown.The patient requested an investigation.The synovitis (severe) was medically significant.Action taken with euflexxa was unknown.At the time of the report, the outcome of severe synovitis was not recovered, the outcome of synovitis led to other knee problems was not recovered, the outcome of reaction in both knees was not recovered.No concomitant medication was reported.The event severe synovitis was reported as serious.The events synovitis led to other knee problems, reaction in both knees were reported as non-serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: synovitis, synovitis which led to other knee problems and reaction in both knees: not related.Patient requesting an investigation: related per convention.Sender comment: important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication, therapy dates, onset dates, product indication etc.Preventing a proper medical assessment.Synovitis may occur in association with arthritis and other conditions although it is also present in many joints affected with osteoarthritis.Due to clinical interpretation in alignment with known safety profile, company causality for the synovitis and the other knee problems is considered not related to euflexxa.Other case numbers: internal # - others = (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.

• 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: 16477864
• MDR Text Key: 310616848
• Report Number: 0002244564-2021-00056
• 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: Pharmacist
• 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
• 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 Age: 61 YR
• Patient Sex: Female