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

Catalog Number 6301182010

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Aneurysm (1708)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Two aneurysms [aneurysm].Has been on euflexxa before but it did not work [device ineffective].Case (b)(4) is a serious spontaneous case received from a non health professional fda from us.This report concerns a female patient of unknown age, who experienced two aneurysms and that euflexxa did not work during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, for unknown indication from an unknown start date and unknown if ongoing.The patient had been on euflexxa before but it did not work and the patient had to have a knee replacement on an unspecified date in 2018.The patient was hospitalized for having two aneurysms on an unknown date in 2019.No additional information was provided.Action taken with euflexxa was unknown.At the time of this report, the outcome of two aneurysms and did not work was unknown.The following concomitant medications were reported: carafate, protonix, duloxetine, amlodipine, zolpidem, triamterene hctz, esomeprazole magnesium, montelukast, buspirone, benazepril , keppra and atorvastatin.The event two aneurysms was reported as serious.The event did not work was reported as non-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: mw5089080.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: 9148233
• MDR Text Key: 167382364
• Report Number: 3000164186-2019-00040
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2019

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: 10/08/2019
• Device Catalogue Number: 6301182010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 10/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization