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 Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Culture of patient's right knee which revealed e.Coli [escherichia infection].Case (b)(4) is a serious spontaneous case received from a health professional in united states.This report concerns a female whose right knee culture revealed e.Coli, after treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration unknown dose, for osteoarthritis from an unknown start date to an unknown stop date.According to the physician's assistant (pa) the patient experienced pain and swelling of her right knee about five days after receiving her first euflexxa injection.The pa did a culture of patient's right knee which revealed e.Coli.As treatment, a wash out of her right knee was done and patient was on iv antibiotics for a few days.The patient was currently on an unspecified oral antibiotic.The office will hold onto the remaining two syringes in case its needed.No further information was provided.The culture revealed e.Coli was medically significant.Action taken with euflexxa was unknown.At the time of the report, the outcome of culture of patient's right knee which revealed e.Coli was unknown.No concomitant medication was 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: (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 does not meet the definition of a medical device incident according to the requirements of the medical device directive/ 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.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 8670874
• MDR Text Key: 147084474
• Report Number: 3000164186-2019-00017
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 06/05/2019

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: No Information
• Device Expiration Date: 09/02/2019
• Device Catalogue Number: 6301182010
• Device Lot Number: N16870A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other