MAUDE Adverse Event Report: EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Diverticulitis [diverticulitis].In one of her past series she had to postpone injections [inappropriate schedule of product administration].Case narrative: case (b)(4) is a serious spontaneous case received from a consumer in united states.This report concerns a female patient of unknown age, who experienced diverticulitis during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, route and dose, for unknown indication from (b)(6) 2019 to an unknown stop date.The patient reported that she had taken euflexxa in the past, started another series on (b)(6) 2019 and had to go the hospital with diverticulitis and was still not feeling well.The patient reported that in one of her past series she had to postpone injections (inappropriate schedule of product administration) as well and noticed a difference which was not clarified.No additional information was provided.The patient was hospitalized on an unknown date in (b)(6) 2019 due to diverticulitis.Action taken with euflexxa was unknown.At the time of this report, the outcome of diverticulitis was not recovered.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 unknown.Overall listedness (core label) is unlisted.Reporter causality: not reported (processed as related).Company causality: not related.Other case numbers: internal # - others = (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
• MDR Report Key: 16443142
• MDR Text Key: 310330082
• Report Number: 0002244564-2019-00034
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• 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
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female