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 Sepsis (2067)

Event Type  Injury  

Event Description

Septic unspecified knee [arthritis bacterial].Case (b)(4) is a serious spontaneous case received from a physician via sales representative in united states.This report concerns a patient (no identifiers reported) who experienced septic unspecified knee during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route and frequency for an unknown indication from (b)(6) 2020 to an unknown stop date.The physician reported the patient developed septic unspecified knee after undergoing series of euflexxa injections two weeks ago ((b)(6) 2020).No additional information the septic unspecified knee was medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of septic unspecified knee was unknown.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not 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.Ferring's sender comment: despite the limited information about the patient's medical and concomitant medications history, therapy details for euflexxa (indication of use, stop date, and route of adminstration) and event details (clinical course, event onset date, and outcome), association of euflexxa to septic joint event is unrelated due to lack of biological plausibility.The event is more likely due to incorrect guidelines for clean aseptic procedure of injection or underlying bacterial infection which were not reported.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; bee'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
• MDR Report Key: 10325845
• MDR Text Key: 208208177
• Report Number: 3000164186-2020-00011
• 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
• Type of Report: Initial
• Report Date: 07/27/2020

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: 02/05/2021
• Device Catalogue Number: 6301182010
• Device Lot Number: R14568A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 07/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other