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 Arthralgia (2355); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2023

Event Type  Injury  

Event Description

Some days the pain is so high that the patient barely get thru daily activities [loss of personal independence in daily activities] the pain not only in my knees but in most of other areas of my body; other areas of my body would have soreness: my hips, legs, shoulders and especially my lower back.[pain] the pain in knees is still very noticeable [arthralgia] case narrative: this is a serious spontaneous case received from a patient via regulatory authority in the united states.This report concerns a patient of an unknown age and gender who experienced the pain not only in my knees but in most of other areas of my body; other areas of my body would have soreness: my hips, legs, shoulders and especially my lower back, the pain in knees was still very noticeable, and some days the pain was so high that the patient barely get thru daily activities during treatment with intraarticular use of euflexxa (sodium hyaluronate) solution for injection, unknown concentration, and dosage regimen for an unknown indication from an unknown date in 2023 to an unknown stop date.On an unknown date in 2023, the patient received three injections of euflexxa into knees.On 01-nov-2023, the patient found that other areas of body experienced soreness, hips, legs, shoulders, and especially lower back.The patient talked to doctor about this, who had no explanation for the soreness but offered to perform surgery on the patient's knees.The patient stated that twelve weeks had passed since the last injection and was still trying to deal with the pain not only in knees but in most of other areas of body.The patient reported that some days, the pain was so high that the patient barely got thru daily activities.The patient took ibuprofen for the pain, but it only lasted for a few hours.The patient stated that the main purpose for reporting this problem was to find out if others had similar reactions and to get ideas of other medication that may have help with the pain.The patient reported that the pain in knees was still very noticeable at the time of reporting.The events of the pain not only in my knees but in most of other areas of my body; other areas of my body would have soreness: my hips, legs, shoulders and especially my lower back, the pain in knees was still very noticeable, and some days the pain was so high that the patient barely got thru daily activities were considered serious due to disability.Action taken to euflexxa was unknown.The outcome of the pain in knees was still very noticeable was not recovered.The outcome of the pain not only in my knees but in most of other areas of my body; other areas of my body would have soreness: my hips, legs, shoulders and especially my lower back, and some days the pain was so high that the patient barely got thru daily activities was unknown.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown for event of loss of personal independence in daily activities and 'not recovered' for events of 'pain' and 'arthralgia'.Overall listedness (core label) is unlisted.Reporter causality: related company causality: unassessable other case numbers: internal # - others = mw5152902.Internal # - others = mw5152903 internal # - others = mw5152904.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 14 june 1993 93/42/eec concerning medical devices) / mdr (eu) 2017/745 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
• Manufacturer (Section G): FERRINGPH; 100 interpace parkway; parsippany 07054
• Manufacturer Contact: pob 571, be'er tuvia industria; l zone; kiryat malachi 83104-02 ; 2542274192
• MDR Report Key: 19081912
• MDR Text Key: 339844553
• Report Number: 3000164186-2024-00022
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2024

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention