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

Catalog Number 6301182010

Device Problem Off-Label Use (1494)

Patient Problems Purulent Discharge (1812); Synovitis (2094)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Synovitis with a purulent secretion [purulent synovitis] off label use [product used for chondropathy on the right knee] [off label use of device] product used for chondropathy on the right knee [product use in unapproved indication] case narrative: this serious, spontaneous case and complaint was received from a physician in brazil.This report concerns a 38-year-old male who experienced synovitis with a purulent secretion during treatment with euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, 0.2 ml, once in a week, for chondropathy on the right knee from (b)(6) 2019 to (b)(6) 2019 (off label use / product use in unapproved indication).Batch number n17652ae.Expiry date feb-2020.On an unknown date in 2019, after the second administration of euflexxa, the patient was diagnosed with synovitis with a purulent secretion on the right knee.The reporter believes that the event was related to administration of euflexxa.The synovitis with a purulent secretion was medically significant.On (b)(6) 2019, the patient underwent surgery for joint cleaning due to the adverse event.Further information regarding this procedure and the outcome were not provided.It was informed by the reporter that: 'the therapy with maxsulid (beta cyclodextrin nimesulide) tablets 400mg was ongoing', but it was not clear if this treatment was concomitant or only a treatment prescribed to treat the adverse event.Action taken to euflexxa was unknown.The following concomitant medication was reported: collagen (from an unknown start date and ongoing).Conclusion from the qa-track report: the investigation did not find any relevant potential root cause in the manufacturing processes.Enveromental monitoring, qc and ipc batch records were reviewed, all results are within limits- without any evidence of contaminaton.Deviations and events were reviewed as well.No clear relation was found to previous complaints.Btg performs a routine trend analysis of all complaint types.If an adverse trend is established, the need for capa will be reevaluated.The complaint is not confirmed.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - affiliate = (b)(4).Internal # - complaint = (b)(4).This ae occurred in brazil 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 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 10-oct-2019: conclusion from qa-track report added to the narrative.

• 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: 16439046
• MDR Text Key: 310228292
• Report Number: 0002244564-2019-00038
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2023

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: 02/01/2020
• Device Catalogue Number: 6301182010
• Device Lot Number: N17652AE
• 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
• Treatment: COLLAGEN (COLLAGEN),
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 38 YR
• Patient Sex: Male