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

Catalog Number 6301182010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Breast Cancer (1759); Cancer (3262)

Event Type  Injury  

Event Description

Hospitalized for thyroid cancer removal surgery [thyroid cancer], breast cancer [breast cancer].Case (b)(6) is a serious spontaneous case received from a pharmacist via fda's medwatch program in united states.This report concerns a female patient of an unknown age, who experienced thyroid cancer removal surgery and breast cancer during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose and frequency for an unknown indication from an unknown start date and unknown if ongoing.The pharmacist reported the patient being hospitalized to have thyroid cancer removal surgery and also she would have more surgery later to remove her breast cancer as well.The breast cancer was medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of hospitalized for thyroid cancer removal surgery and breast cancer were unknown.The patient's med hist/ procedure was significant for thyroid cancer surgery (from unknown start date to unknown stop date).The following concomitant medication was reported: oxybutynin (from an unknown start date to an unknown stop date).All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related, company causality: not related.Ferring sender comment: this report contains very limited information.However, based on the known safety profile of euflexxa it is considered highly unlikely that euflexxa was involved in causing the thyroid and breast cancer in this patient.Company causality is not related.Other case numbers: internal # others = mw5099613.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 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.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 11607208
• MDR Text Key: 260827901
• Report Number: 3000164186-2021-00012
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 04/02/2021

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: No Information
• Device Catalogue Number: 6301182010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other