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

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Test Result (2695)

Event Date 05/20/2019

Event Type  Injury  

Event Description

Suspicion of septic arthritis [arthritis bacterial].Case (b)(6) is a serious spontaneous case received from a physician in (b)(6).This report concerns a (b)(6)-year-old female, who experienced suspicion of septic arthritis during treatment with intra-articular arthrease (sodium hyaluronate) solution for injection, unknown concentration, at a dose of 1 injection in both knees, for osteoarthritis on (b)(6) 2019.Batch number not available.The patient`s medical history included diabetes, eczema on legs, osteoarthritis in both knees, metabolic syndrome and bmi >35.Due to the patient's complex medical condition, surgical management was not an option and although her knees where ruined, arthrease was suggested to provide some relief.On (b)(6) 2019, the physician injected artherase to both knees: on one knee, there were no issues, but on the other knee, after the injection the patient experienced extreme pain, that did not resolve.The physician performed an articular puncture and the extracted synovial fluid was bloody.An analysis of the synovial fluid revealed increased leukocytes (over 80,000); no bacterial presence was noted.The patient also had an increased crp.Following the articular leukocytosis, septic arthrosis was suspected and the patient was hospitalized.Action taken to arthrease was unknown.At the time of the report, the patient was still in a hospital and the outcome was not recovered.No concomitant medication was reported.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: unassessable.Other case numbers: internal # - (b)(4).This ae occurred in (b)(6) and concerns the medical device arthrease.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: 8695225
• MDR Text Key: 147863567
• Report Number: 3000164186-2019-00018
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR