MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Covid [covid-19], thick kidney [renal disorder] and enlarged spleen [splenomegaly].Case narrative: this is a serious spontaneous case received from a health professional via regulatory authority in united states.This report concerns a female of unknown age who had covid, thick kidney, and an enlarged spleen during treatment with intraarticular use euflexxa (sodium hyaluronate) solution for injection 10 mg/ml 2ml, weekly for three weeks, for an unknown indication from an unknown start date to an unknown stop date.The reporter stated that the patient had new diagnoses of thick kidney and enlarged spleen and was on new medications for these.She also had covid and was in the hospital (dates not provided).The patient was hospitalised on an unknown date due to covid.Action taken with euflexxa was unknown.At the time of this report, the outcome of the events was unknown.No concomitant medication or medial history were reported.The event covid was reported as serious.The events thick kidney, enlarged spleen were reported as non-serious.At the time of reporting the case outcome was unknown.Sender comment: the association between euflexxa and covid-19, renal disorder, and splenomegaly is not related due to lack of biological plausibility.Further assessment is precluded by the limited information provided in the case.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = mw5110772.(b)(4).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 medical device directive/ 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.; 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: 15115594
• MDR Text Key: 296757112
• Report Number: 3000164186-2022-00030
• 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: 07/26/2022

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: 07/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female