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 Pain (1994)

Event Type  Injury  

Event Description

A day after second injection in left knee, right foot started "killing" him, got better, then left foot started "killing" him, then both feet hurt, severe neuropathy [neuropathy peripheral].Case narrative: this serious spontaneous case received from a consumer in the united states.This report concerns a 62-year-old male patient who experienced his right foot started "killing" him, got better, then his left foot started "killing" him and then both feet hurt; severe neuropathy, a day after his second injection in left knee, during treatment with euflexxa (sodium hyaluronate) solution for injection 1%, unknown route, three weekly injections for three weeks in left knee, for an unknown indication from (b)(6) 2022 to (b)(6) 2022.The patient reported he received euflexxa series in his left knee during the first three weeks in (b)(6) 2022.The patient reported the day after his second injection, his right foot started "killing" him, that got better, then his left foot started "killing" him, and then both feet hurt.The pain eventually subsided.The patient went back for his third injection, informed his doctor about it, who determined it was plantar fasciitis.The patient went to a podiatrist who referred him to a neuro surgeon, who diagnosed it as severe neuropathy.Prior to euflexxa injections about 14 years ago, the patient reported he had mild neuropathy in his feet due to chemotherapy.The patient stated he did very well with euflexxa and prior to the injections he walked with a cane and two days after his first injection, he no longer needed the cane.The patient stated he eventually had magnetic resonance imaging (mris) and a nerve conduction study of his feet.No further information provided.Patient also reported he did very well with euflexxa and prior to injections was walking with a cane and 2 days after his 1st injection, he no longer needed the cane.He reported his results in his knee were good.Action taken with euflexxa was not applicable.At the time of this report, the outcome of a day after second injection in left knee, right foot started & "killing" him, got better, then left foot started and "killing" him, then both feet hurt; severe neuropathy, was unknown.The patient's med hist/procedure was significant for mris (from unknown start date to unknown stop date) and nerve conduction study (from unknown start date to unknown stop date) and chemotherapy (from unknown start date to unknown stop date), mild neuropathy (from 2008 to unknown stop date), and left hip replacement (from unknown start date to unknown stop date.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was resolving/recovering.Sender comment: due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa due to a pre-existing neuropathy in his feet diagnosed in 2008 (due to chemotherapy) with no stop date being this one part of the patient's current medical history.Furthermore, the patient reported results in his knee with euflexxa were good.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = (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
• MDR Report Key: 16477871
• MDR Text Key: 310605959
• Report Number: 0002244564-2022-00032
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2023

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: Health Professional
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: LOSARTAN (LOSARTAN).; VITAMINE B COMPLEX (VITAMIN B COMPLEX).
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 66 KG