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 Bruise/Contusion (1754); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Drag my legs around, works and has to climb ladders, has to prep by icing legs, putting icy hot all over [loss of personal independence in daily activities], bruising all the way from knee down to ankle, little calf pain, in worse pain now than before [contusion], left calf is 2 inches bigger than the right [peripheral swelling], little calf pain [pain in extremity].Case narrative: this case is a serious spontaneous complaint case was received from a consumer in the united states.This report concerns a female patient who experienced little calf pain and bruising all the way from knee down to ankle during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route, and frequency, for unknown indication from an unknown start date to unknown stop date.On an unknown date, the consumer reported that the patient has received all three injections of euflexxa in both knees and can´t seem to get the pain in her calves alleviated.After the second injection, she experienced a little calf pain, and she told her physician about that before she had the third injection.She said the physician dismissed her and gave her the third injection anyway and her knees were feeling good.The consumer reported by the fourth week, bruising all the way from the knee down to the ankle and she dragged her legs around.Her left calf was 2 inches bigger than her right calf and was negative for a blood clot.The patient had not heard back from the orthopedic doctor's office who gave the injections and will not tell her how to handle the pain.She works and has to climb ladders and prepare for every day by icing her legs, and putting icy hot all over as she was in worse pain, than she has before.The patient was disabled or suffered permanent damage due to bruising all the way from knee down to ankle.Action taken to euflexxa was not applicable.The outcome of drag my legs around, works and has to climb ladders, has to prep by icing legs, putting icy hot all over was unknown, the outcome of bruising all the way from knee down to ankle, little calf pain, in worse pain now than before was unknown, the outcome of left calf is 2 inches bigger than the right was unknown, the outcome of little calf pain was unknown.No concomitant medication was reported.The event drag my legs around, works and has to climb ladders, has to prep by icing legs, putting icy hot all over was reported as serious.The events bruising all the way from knee down to ankle, little calf pain, in worse pain now than before, left calf is 2 inches bigger than the right, little calf pain was reported as non-serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = (b)(4).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 mdd (european council directive of (b)(6)1993 93/42/eec concerning medical devices) / mdr (eu) (b)(4) and/or because it did not occur in an eu + efta country + tr and ni 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: 18174225
• MDR Text Key: 328615608
• Report Number: 0002244564-2023-00058
• 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: 11/20/2023

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: 11/20/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Female