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 Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Patient broke out in hives [urticaria] case narrative: this is a serious spontaneous case received from a health professional and patient's daughter via regulatory authority in the united states.This report concerns a female patient of unknown age who broke out in hives during treatment with intraarticular use euflexxa (sodium hyaluronate) solution for injection, unknown concentration.The dosage regimen consisted of three doses of two milliliters administered once weekly for three weeks, used for unknown indication from an unknown start date to an unknown stop date.On an unknown date, the patient's daughter reported that her mother was unable to take medication due to reaction in 2023.The reporter stated that the patient broke out in hives, was hospitalized and as a result she could not complete the treatment.The exact dates of hospitalization and the duration of stay were unknown, and it was unclear whether a specialist was informed of the situation.Action taken with euflexxa 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: the contribution of sodium hyaluronate to urticaria could not be excluded due to known safety profile of hyaluronan preparations.The conservative assessment of the causality was based on the limited information provided in the report.Overall listedness (core label) is unlisted.Reporter causality: related company causality: related other case numbers: internal # - others = mw5152460 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 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: 18999350
• MDR Text Key: 338882788
• Report Number: 3000164186-2024-00021
• 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: 03/27/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female