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

Catalog Number 6301182010

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Back surgery [spinal operation].Case narrative: (b)(4) is a serious spontaneous case received from a pharmacist via a regulatory authority in the united states.This report concerns a female of unknown age who had back surgery during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown dose and frequency, for unknown indication from an unknown start date to an unknown stop date.A pharmacist reported that the patient had back surgery four weeks ago ((b)(6)2021).Treatment included albuterol hfa; atorvastatin, buspirone, cephalexin, clopidogrel, cyclobenazprine, diclonfenac gel, duloxetine, mirtazapine, myrbetriiq, nortriptyline, orphenadrine er, trazodone.No other information was provided.The back surgery was medically significant.Action taken with euflexxa was unknown.At the time of reporting, the outcome of back surgery 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.Sender comment: very limited and important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication, product indication, administration dates, as well as the details relating to the surgery of the patient preventing a proper medical assessment.Based on this and the well-known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's back surgery.Company causality unrelated.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = mw5105498.Mw 3500a mfr.Rpt.# = 3000164186-2022-00002.E2b company number = us-ferringph-2022fe00077.Health effect - clinical code: 4580 (insufficient information).Medical device problem code: 3190 (insufficient information).Additional information received on 10-jan-2022 from pharmacist: follow up 01: health effect - clinical course and medical device problem codes added.Updated references numbers.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.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• MDR Report Key: 16477862
• MDR Text Key: 310648571
• Report Number: 0002244564-2022-00002
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female