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 Anemia (1706)

Event Date 12/20/2019

Event Type  Injury  

Event Description

Anemic [anaemia] case (b)(6) is a serious spontaneous case received from a consumer via regulatory authority in united states.This report concerns a patient (no identifiers reported) who was anemic during treatment with euflexxa (sodium hyaluronate) solution for injection 1 %, 10mg/1ml, unknown dose and frequency for an unknown indication from an unknown start date and unknown if ongoing the patient was in the hospital due to being anemic and stated that they added an antacid for 30 days but did not know the name of it.The patient had no missed dose.The patient was hospitalized on an unknown date due to anemic.Action taken with euflexxa was unknown.At the time of the report, the outcome of anemic 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.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Sender comment (ferring): this case contains very limited information, especially current conditions and medical history, incl.Concomitant medication which is essential information for a proper causality assessment, have not been reported.However, based on the known safety profile of euflexxa, it is considered highly unlikely that euflexxa was involved in causing the anaemia.Company causality is not related.Other case numbers: internal # - others = mw5091958 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 ; 3044828
• MDR Report Key: 9694403
• MDR Text Key: 178599001
• Report Number: 3000164186-2020-00003
• 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: 01/29/2020

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: No Information
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization