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); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 09/12/2019

Event Type  Injury  

Event Description

Could not walk [gait inability].Could not bend knee at all [joint range of motion decreased].Extremely painful [pain].Severe swelling in knee [joint swelling].Case narrative: (b)(4) is a serious spontaneous case received from a consumer via regulatory authority in united states.This report concerns a patient (no identifiers reported) who could not bend knee at all, could not walk, extremely painful and severe swelling in knee during treatment with euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, unknown dose, for an unknown indication from an unknown start date to an unknown stop date.The patient got an injection of euflexxa and after that could not bend knee at all.The patient had received orthovisc shots previously and did not react the same way.The patient could not walk, extremely painful of knee and severe swelling in knee.The events of could not bend knee at all, could not walk, extremely painful of knee and severe swelling in knee were medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of could not bend knee at all was unknown, the outcome of could not walk was unknown, the outcome of extremely painful was unknown, the outcome of severe swelling in knee was unknown.The patient's past drug therapy was significant for orthovisc shots (from unknown start date to unknown stop date).The following concomitant medications were reported: xyzal (from an unknown start date to an unknown stop date), singulair (from an unknown start date to an unknown stop date), loestrin fe (from an unknown start date to an unknown stop date).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).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
• MDR Report Key: 16438980
• MDR Text Key: 310288449
• Report Number: 0002244564-2019-00046
• 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: 02/22/2023

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: 02/24/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: LOESTRIN FE (ETHINYLESTRADIOL, FERROUS FUMARATE, N.; SINGULAIR (MONTELUKAST SODIUM).; XYZAL (LEVOCETIRIZINE DIHYDROCHLORIDE).
• Patient Outcome(s): Other; Required Intervention