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 Problems Death (1802); Underdose (2542)

Event Date 05/07/2018

Event Type  Death  

Event Description

Patient passed away [death].Oral route of administration [incorrect route of drug administration].Dose was 10mg [underdose] was given daily [inappropriate schedule of drug administration.] case (b)(6) is a serious, spontaneous case received from a non health professional via a regulatory authority in the united states.This report concerns a patient of unknown age and gender who passed away and experienced the wrong route of administration [orally], underdose [10 mg], and inappropriate schedule of drug administration [weekly] during treatment with oral euflexxa (sodium hyaluronate) solution for injection, unknown concentration, 10 mg, daily, for an unknown indication from 2018 to an unknown stop date.On an unknown date, the patient received product via the wrong route of administration, reported as administered orally, underdose, and inappropriate schedule of drug administration.On (b)(6) 2018, the patient passed away.The patient died on (b)(6) 2018 due to an unknown reason.Action taken with euflexxa was not applicable.At the time of this report, the outcome of patient passed away was fatal, the outcome of oral route of administration was unknown.Concomitant medication was not reported.The event patient passed away was reported as serious.The event oral route of administration was reported as non-serious.At the time of reporting the case outcome was fatal.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: unassessable.Other case numbers: case number, others = mw5077911.This ae occurred in the us 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.

• 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: 8005678
• MDR Text Key: 125035561
• Report Number: 3000164186-2018-00030
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2018

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 Catalogue Number: 6301182010
• Device Lot Number: N14371A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/25/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death