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 Headache (1880); Pain (1994); Myalgia (2238); Arthralgia (2355); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Muscle pain [myalgia].Slight aches and pain [pain].Could not function for three days [loss of personal independence in daily activities].Joint pain [arthralgia].Headache [headache].Case narrative: this is a serious spontaneous case received from a consumer via regulatory authority in the united states.This report concerns a female patient of unknown age, who experienced muscle pain, joint pain, slight aches and pain, could not function for three days, and headache during treatment with intraarticular use euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, 1 injection weekly for three weeks, used for unknown indication from an unknown start date to an unknown stop date.The patient reported that they had an euflexxa injection in their left knee and experienced muscle and joint pain from head to toe late that evening for three and a half days.The patient reported that they could not function for three days and had headache.After the second injection, the patient experienced slight aches and pain, but had lingering joint and muscle pain that seemed to travel throughout their body.Action taken with euflexxa was not applicable.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the outcome of the events of joint and muscle pain was not recovered, the outcome of the events of headache and pain was unknown, and the outcome of the event of could not function for three days was recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = mw5145807.Internal # - others = mw5145808.Internal # - others = mw5145809.1880:headache, 1994: pain; 2238:myalgia; 2355:arthralgia 4535:unspecified musculoskeletal problem.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: 17890915
• MDR Text Key: 325274936
• Report Number: 3000164186-2023-00045
• 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
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female