MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD EUFLEXXA; 1 % SODIUM HYALURONATE

Catalog Number 6301182010

Device Problems Incorrect Software Programming Calculations (1495); Application Program Problem: Medication Error (3198)

Patient Problem No Information (3190)

Event Date 05/01/2017

Event Type  Injury  

Event Description

Hospitalized [hospitalisation].Administered via subcutaneous route [incorrect route of drug administration].Dose of 10 mg [incorrect dose administered by device].This serious, regulatory authority, spontaneous report was received from a pharmacist in united states.This report concerns a patient of unknown age and gender who was hospitalized, administered euflexxa via subcutaneous route, and received a dose of 10 mg during treatment with subcutaneous euflexxa (sodium hyaluronate) solution for injection unknown concentration 10 mg, weekly, for osteoarthritis from 2015 and ongoing.It was reported that the patient was hospitalized for an unknown reason.Dates of hospitalization and treatment received were not reported.The patient received euflexxa subcutaneously (the approved route is intra-articular) and the dose was 10 mg (the approved dose is 2 ml).The event of hospitalization was deemed serious due to hospitalisation.Action taken with euflexxa was dose not changed.At the time of this report, the outcome was unknown.Concomitant medication use and medical history were not reported.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: case number, others = mw5070755.This ae occurred in the us 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.(b)(4).

• Brand Name: EUFLEXXA
• Type of Device: 1 % SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737967600
• MDR Report Key: 6739838
• MDR Text Key: 80894100
• Report Number: 3000164186-2017-00024
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2017
• Device Catalogue Number: 6301182010
• Device Lot Number: M12039A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization