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 Problem Cancer (3262)

Event Date 10/02/2018

Event Type  Injury  

Event Description

Mds (myelodysplastic syndrome) [myelodysplastic syndrome].Case (b)(4) is a serious spontaneous case received from a non health professional via regulatory authority in the united states.This report concerns a female of unknown age who experienced mds (myelodysplastic syndrome) during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection, 10 mg, dose unknown, weekly, for osteoarthritis from an unknown start date to an unknown stop date.The patient reported she was diagnosed with mds (myelodysplastic syndrome) in 2018.Patient reported she underwent chemotherapy from 2017 to 2018 and is no longer on chemotherapy since it did not produce the results that were hoped.Medical doctor's office (mdo) is aware and has cleared her for euflexxa injections.Event did not stop after use stopped or dose reduced.Event did not reappear after reintroduction.The event of mds (myelodysplastic syndrome) was medically significant.Action taken to euflexxa was dose reduced.On an unknown date, the outcome of mds (myelodysplastic syndrome) was unknown.The patient's medical history was significant for chemotherapy (from 2017 to 2018).The following concomitant medications were reported: probiotic (from an unknown start date to an unknown stop date), vitamin d3 (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.Other case numbers: case number, others = mw5080429.This ae occurred in us 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: 8094781
• MDR Text Key: 128056563
• Report Number: 3000164186-2018-00039
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• 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
• Date Manufacturer Received: 11/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PROBIOTIC; VITAMIN D3
• Patient Outcome(s): Congenital Anomaly; Other