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 Inflammation (1932); Pain (1994); Joint Contracture (4528); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/11/2023

Event Type  Injury  

Event Description

Fingers were contracted [joint contracture].Inflammation [inflammation].All over body pain [pain].Adverse reaction [adverse drug reaction].Case narrative: this is a serious spontaneous case received from a consumer in the united states.This report concerns a male of unknown age who experienced fingers were contracted, inflammation, all over body pain and adverse reaction during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, and route, 1 injection weekly for three weeks , used for unknown indication from an unknown start date to an unknown stop date.On (b)(6) 2023, the reporter stated that he received three doses of euflexxa injections and had an adverse reaction after the third injection.The patient reported that his fingers were contracted, he had inflammation, and all over body pain.The patient stated that it took some few hours before he regained movements of his extremities and his primary care physician placed him on prednisone for 10 days to decrease discomfort and pain but after ten days the symptoms returned.All events were medically significant.Action taken with euflexxa was not applicable.No concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = mw5144526.1932: inflammation, 1994:pain.4528:joint contracture.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: 17739362
• MDR Text Key: 323320774
• Report Number: 3000164186-2023-00039
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male