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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Burning Sensation (2146); Arthralgia (2355); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Suicidal Ideation (4429); Swelling/ Edema (4577)

Event Date 10/21/2020

Event Type  Injury  

Event Description

Severe mobility issues [mobility decreased].Want to end life [suicidal ideation].Can hardly walk [gait disturbance].Affecting job and what i do at home [loss of personal independence in daily activities].Edema [oedema].Swelling fluid cyst deep in knee [cyst].Can't sleep [insomnia].Pain in right knee was excruciating [arthralgia].Knee burns [arthralgia].Pain traveling into hip and low back [arthralgia].Pain traveling into hip and low back [back pain].Stopped refused more injections [refusal of treatment by patient].Case narrative: case (b)(4) is a serious spontaneous case received from a consumer via regulatory authority in united states.This report concerns a male patient of unknown age, who experienced severe mobility issues, wanted to end life, can hardly walk, edema, swelling fluid cyst deep in knee, can't sleep, pain in right knee was excruciating, knee burns, pain traveling into hip and low back, refuse more injections and affecting job and what he does at home during treatment with intra articular euflexxa (sodium hyaluronate) solution for injection, unknown concentration and dose, for unknown indication from an unknown start date to an unknown stop date.The patient reported that after he received the euflexxa injection in right knee, the pain was excruciating, his knee burned, edema and experienced such swelling fluid cysts developed deep in the knee.The patient stated that he had a torn meniscus removed a year prior and was getting steroid injections which were helping.The patient stated that the doctor recommended a better euflexxa injection for long relief.The patient reported that well after the euflexxa injection, he could hardly walk, the pain was so bad that he wanted to end his life at the time and he couldn't sleep.The pain was traveling into the hip and lower back.The patient stated he thought that this was supposed to provide a long term solution to steroids which were ok.This was affecting his job, what he did at home and was now battling constant level 11 pain daily.The patient was extremely upset and was worried about walking again.The patient wondered if there was any solution to the severe mobility issues, pain and edema and wondered if "this stuff" could be drained from the knee.The patient considered this "nasty and debilitating medication" and refused injections.No additional information was provided.The can hardly walk was medically significant.The want to end life was medically significant.The patient was disabled or suffered permanent damage due to severe mobility issues.Action taken with euflexxa was unknown.At the time of this report, the outcome of severe mobility issues, want to end life, can hardly walk, edema, swelling fluid cysts deep in knee, can't sleep, pain in right knee was excruciating, knee burns, pain traveling into hip and low back and affecting job and what he does at home was not recovered.The patient's med hist/procedure was significant for torn meniscus (from unknown start date to unknown stop date).The patient's past drug therapy was significant for steroids (from unknown start date to unknown stop date).The following concomitant medication was reported: hydrocortisone (from an unknown start date to an unknown stop date), ibuprofen (from an unknown start date to an unknown stop date), calcium (from an unknown start date to an unknown stop date), magnesium (from an unknown start date to an unknown stop date), vitamin c [ascorbic acid;sodium ascorbate] (from an unknown start date to an unknown stop date).The events severe mobility issues, want to end life, can hardly walk were reported as serious.The events edema, swelling fluid cyst deep in knee, can't sleep, pain in right knee was excruciating, knee burns, pain traveling into hip and low back, refusal of treatment by patient and pain traveling into hip and low back were reported as non-serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: #mw5097816, e2b company number: (b)(4).Medwatch #: 3000164186-2020-00016.Ferring sender´s comment: due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the 'suicidal ideation', 'oedema', 'cyst', and 'insomnia' events as there is no clinical evidence, but might most likely related to the reported pain.Amendment 04-dec-2020: reporting sentences added to the bottom of the narrative.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.Additional information was received from a consumer via regulatory authority on 04-may-2022: follow up 01: route of administration for euflexxa was updated to intra articular (previously reported but not captured).

• 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: 16438999
• MDR Text Key: 310243022
• Report Number: 0002244564-2020-00016
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2023

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: 02/24/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: CALCIUM (CALCIUM),; HYDROCORTISONE (HYDROCORTISONE),; IBUPROFEN (IBUPROFEN),; MAGNESIUM (MAGNESIUM),; VITAMIN C [ASCORBIC ACID,SODIUM ASCORBATE] (ASCORB)
• Patient Outcome(s): Disability; Other
• Patient Sex: Male