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 Discomfort (2330); Unspecified Tissue Injury (4559)

Event Date 10/12/2021

Event Type  Injury  

Event Description

Fullness and discomfort of injection [injection site discomfort].Case narrative: case (b)(4) is a serious spontaneous case received from a consumer via a regulatory authority in united states.This report concerns a male of unknown age who experienced fullness and discomfort of injection during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown dose and frequency, for osteoarthritis from 2021 to an unknown stop date.The patient reported that he underwent routine knee injection for thinning cartilage.One week after first injection((b)(6) 2021), fullness and discomfort of injection still persisted.The consumer stated that there was no mention in the literature or drug website that this might happen.Per patient, future patients, especially active ones, should have expectations set appropriately that they may not be able to resume exercise more than a week later.It was reported that the patient was disabled or suffered permanent damage due to fullness and discomfort of injection.Action taken with euflexxa was unknown.At the time of reporting, the outcome of fullness and discomfort of injection was not recovered (reported as disability/permanent damage).No concomitant medication was reported.The event fullness and discomfort of injection was reported as serious (with outcome of disability/permanent damage).Overall listedness (core label) is listed.Reporter causality: related.Company causality: related.Ferring sender comment: the reported narrative does not indicate any disability/permanent damage.However, as the event outcome has been reported as disability/permanent damage, the case has been processed as serious.Other case numbers: internal # - others = mw5104634.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 did not occur in a eu + efta country 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: 16214438
• MDR Text Key: 307838277
• Report Number: 3000164186-2021-00049
• 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: 01/19/2023

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: 01/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Male