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

Catalog Number 6301182010

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Swelling (2091); Joint Swelling (2356); Joint Disorder (2373); Ambulation Difficulties (2544)

Event Date 11/20/2016

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Haemarthrosis.Could not walk due to amount of swelling [abasia].Worsening pain [arthralgia].Swelling of left knee.This serious spontaneous report was initially received from a consumer in united states.Follow up was received from a physician on (b)(6) 2017.Case initially reported as non-serious but upgraded to serious on (b)(6) 2017.This report concerns a (b)(6) male who experienced haemarthrosis, could not walk due to amount of swelling, worsening pain, and swelling of left knee during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, for osteoarthritis from (b)(6) 2016.It was reported that the patient only received two of the three injections.The patient was given his first euflexxa injections in both knees on (b)(6) 2016.After the second set of injections on (b)(6) 2016, he developed swelling in his left knee.He could not walk, due to the amount of swelling, and was taken to the er.He reported that they aspirated blood but was found to not have an infection.The swelling was gone but his pain was worse than before the series began.The physician reported on follow up that 5 days after the second euflexxa injection the patient developed haemarthrosis in his left knee (treatment and outcome are unknown).The physician reported the causality between euflexxa and swelling of the knee as unlikely.Lot number was reported as l16602a.Action taken with euflexxa was dose withdrawn.At the time of this report, the outcome of haemarthrosis was unknown, the outcome of worsening pain was not recovered, the outcome of swelling of left knee was recovered, and the outcome of could not walk due to amount of swelling was unknown.The patient`s medical history was significant for ex-smoke, hypertension, and alcohol use.The patient`s procedure was significant for bilateral x-ray of the knees (from (b)(6) 2016) and aspirated blood.The following concomitant medication was reported: losartan, depomedrol (from (b)(6) 2016 to unknown), and dexamethasone (from 18-oct-2016 to unknown).At the time of reporting the case outcome was unknown.Additional information received on (b)(6) 2017 from patient's physician: case upgraded to serious due to medically significant event.Procedure and medical history updated.Serious event added and narrative updated.Physician reported that patient has transitioned care to another physician and has no additional information.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: (b)(4).The aes occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.The aes are 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.(b)(4).

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 6352654
• MDR Text Key: 68122796
• Report Number: 3000164186-2017-00002
• 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: Physician
• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• 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
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DEPOMEDROL (METHYLPREDNISOLONE ACETATE); DEXAMETHASONE (DEXAMETHASONE); LOSARTAN (LOSARTAN)
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 81