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 Intracranial Hemorrhage (1891); Convulsion/Seizure (4406)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Seizure [seizure].Brain bleed [cerebral haemorrhage].Case narrative: this is a serious spontaneous case received from a health professional via regulatory authority in the united states.This report concerns a male patient of unknown age who experienced a seizure and brain bleed during treatment with intraarticular use euflexxa (sodium hyaluronate) solution for injection unknown concentration, and dose, 1 injection weekly for three weeks into each knee, for unknown indication from an unknown start date to an unknown stop date.The health professional reported that the patient experienced a brain bleed and had surgery for it on an unspecified date in 2023.Two weeks later, while at the doctor's office getting the staples out of his head, the patient experienced a seizure but his doctor told him that it was normal after the type of surgery he had.The brain bleed was medically significant.The seizure was medically significant.Action taken with euflexxa was unknown.Concomitant medication and medical history were not reported.All events in the case were reported as serious.At the time of reporting the case outcome was recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal#: others = mw5148244.This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.Applicable (i.E.For distributed us cases) add the following at the bottom of the narrative: 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 mdd (european council directive of 14 june 1993 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni 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
• Manufacturer (Section G): FERRINGPH; 100 interpace parkway; parsippany 07054
• Manufacturer Contact: pob 571, be'er tuvia industria; l zone; kiryat malachi 83104-02 ; 2542274192
• MDR Report Key: 18336111
• MDR Text Key: 330668253
• Report Number: 3000164186-2023-00063
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2023

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: Health Professional
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male