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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cyst(s) (1800); Pain (1994); 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 (b)(4) is a serious spontaneous case received from a consumer via the fda 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 euflexxa (sodium hyaluronate) solution for injection unknown route, 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: internal # - others = mw5097816.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.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; bee'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
• MDR Report Key: 10936804
• MDR Text Key: 219303728
• Report Number: 3000164186-2020-00016
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CALCIUM (CALCIUM); HYDROCORTISONE (HYDROCORTISONE); IBUPROFEN (IBUPROFEN); MAGNESIUM (MAGNESIUM); VITAMIN C [ASCORBIC ACID,SODIUM ASCORBATE]
• Patient Outcome(s): Other; Disability