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

Catalog Number 6301182010

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Prostate cancer [prostate cancer].Case narrative: case (b)(4) is a serious spontaneous case received from a pharmacist via regulatory authority in united states.This report concerns a male of unknown age who experienced prostate cancer during treatment with intraarticular use euflexxa (sodium hyaluronate) solution for injection, 10 mg/ml 2 ml (on syringe), every week for three weeks, for an unknown indication from an unknown date in 2022 to an unknown stop date.On (b)(6) 2022, the patient was diagnosed with prostate cancer.The prostate cancer was medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of prostate cancer was unknown.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Sender comment: based on the known safety profile, when used according to label and clinical interpretation in alignment with known safety profile, it is considered highly unlikely that euflexxa caused the patient's prostate cancer as there is no clinical evidence.Furthermore, very limited and important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication, product indication and administration dates, preventing a proper medical assessment.Company causality not related.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = mw5110090.(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
• 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: 14834471
• MDR Text Key: 294880915
• Report Number: 3000164186-2022-00027
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• 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
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male