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 Memory Loss/Impairment (1958)

Event Date 08/27/2019

Event Type  Injury  

Event Description

Episodic global amnesia [amnesia].Case (b)(4) is a serious spontaneous case received from a consumer via regulatory authority in united states.This report concerns a female who experienced episodic global amnesia during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, for bilateral primary osteoarthritis from an unknown start date to an unknown stop date.The patient reported that she had episodic global amnesia.The patient was hospitalized on (b)(6) 2019 due to episodic global amnesia.Action taken with euflexxa was unknown.At the time of this report, the outcome of episodic global amnesia was unknown.The following concomitant medications were reported: celebrex, centrum, flexeril, lisinopril, pantoprazole, simvastatin, stimate, zoloft, lorazepam (from an unknown start date to an unknown stop date).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 = mw5089502.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.

• 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 ; 8443044828
• MDR Report Key: 9202855
• MDR Text Key: 175063377
• Report Number: 3000164186-2019-00045
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6301182010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization