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

Event Date 09/06/2023

Event Type  Injury  

Event Description

Underwent unspecified back surgery [spinal operation].Back pain [back pain].Joint pain [arthralgia].Case narrative: this is a serious spontaneous case received from a consumer in the united states.This report concerns a female patient who experienced back pain, joint pain and underwent unspecified back surgery during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route, and frequency, for unknown indication for over the past 12-14 years.On an unknown date, the consumer reported that the patient has a history of euflexxa treatment over the past 12-14 years and for a day or two after each injection, the patient experienced back pain and joint pain, and it was stated that it was not serious.On (b)(6) 2023, the patient underwent back surgery for an unspecified condition.The back surgery was medically significant.Action taken with euflexxa was dose not changed.No concomitant medication was reported.The event underwent unspecified back surgery was reported as serious.The events back pain, joint 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).Sender comment: limited information regarding e.G.Surgery indication, euflexxa therapy dates, concomitant medication, etc.Was available, hence, it is difficult to perform a thorough medical evaluation.However, despite euflexxa's well know safety profile, due to lack of relevant information a causal relationship cannot be ruled out.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 (b)(4) 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
• 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: 18105020
• MDR Text Key: 327877588
• Report Number: 3000164186-2023-00057
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2023

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: 11/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female