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 Pain (1994); Therapeutic Effects, Unexpected (2099); Disability (2371); Ambulation Difficulties (2544)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Hardly move one leg [movement disorder].Hardly able to walk [gait disturbance].Knees got worse, pain has gotten worse since receiving the first injection [pain].No improvement after receiving all 3 injections [device ineffective].Pain in the legs [pain in extremity].This non-serious spontaneous, complaint report was received from a consumer in united states.Case upgraded to serious upon follow up received on 29 april 2016.This report concerns a (b)(6) female who experienced hardly able to move leg, hardly able to walk, knees got worse, pain has gotten worse since receiving the first injection, no improvement after receiving all 3 injections, and pain in the legs during treatment with euflexxa (sodium hyaluronate) solution for injection 1 %, one injection weekly for 3 injections, for osteoarthritis from (b)(6) 2016.The patient reported that she was prescribed euflexxa 1% injection for the treatment of osteoarthritis of both of her knees.She reported no improvement after receiving all 3 injections, knees got worse, pain in the legs and hardly able to walk after receiving all three injections of euflexxa.She reported that she received the first injection on (b)(6) 2016, the second injection on (b)(6) 2016, and the third injection on (b)(6) 2016.She reported that the events started after she received the first injection on both of her knees and the symptoms became progressively worse after each injection was administered.The patient reported that as a result of taking euflexxa she has more pain and can hardly move one of her legs.She reported that she works and it has become a problem for her with the pain and mobility.Action taken with euflexxa was dose not changed.On an unknown date, the outcome of hardly able to walk, knees got worse, pain has gotten worse since receiving the first injection, and pain in the legs was not recovered.The outcome of no improvement after receiving all 3 injections and hardly move one leg was unknown.The patient`s medical history was significant for diabetes and high blood pressure.The following concomitant medication was reported: acarbose, acetaminophen, furosemide, glimepiride, lantus, loratadine, losartan, sertraline, tramadol, ventolin, victoza, aspirin, chromium picolinate, vitamin b12, vitamin d3, ferrous sulfate, an unknown p-colrite tab, unspecified vitamin supplement, needles, contour strips.At the time of reporting the case outcome was unknown.Additional information was received on 29 april 2016: case was upgraded to serious with criteria of disability.Euflexxa lot number was added.Adverse event added.Seriousness criteria updated.Narrative updated.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.This ae does not meet the definition of a medical device incident according to the requirements of the medical device directive and did not result in a corrective action by the manufacturer.Other case numbers: (b)(4), others=mw5061298.

• 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: 5683126
• MDR Text Key: 46095105
• Report Number: 3000164186-2016-00008
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6301182010
• Device Lot Number: 6309501100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2016
• 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
• Patient Outcome(s): Disability
• Patient Age: 67 YR