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

Catalog Number 6301182010

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Arthritis (1723); Inflammation (1932); Pain (1994)

Event Type  Injury  

Event Description

Seronegative spondyloarthropathy [seronegative arthritis] seronegative spondyloarthropathy [spondyloarthropathy] knee pain [device use for unapproved indication] [device use issue] off label use [off label use] case narrative: case 2021fe02163 is a serious spontaneous case received from a physician in united states.This report concerns a female patient (no identifiers reported) who experienced seronegative spondyloarthropathy, knee pain [device use for unapproved indication] and off label use during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, dose, route and frequency for knee pain from an unknown start date to an unknown stop date.The physician reported the patient received the series of three injections for knee pain, and then in ensuing weeks developed what seemed like a seronegative spondyloarthropathy, and wanted to know if this was an occurrence that had happened elsewhere, and if there was any way it can be effectively treated other than oral prednisone.The seronegative spondyloarthropathy was medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of seronegative spondyloarthropathy was unknown, the outcome of knee pain [device use for unapproved indication] was recovered, the outcome of off label use was recovered.No concomitant medication was reported.The event seronegative spondyloarthropathy was reported as serious.The events knee pain [device use for unapproved indication], off label use were reported as non-serious.At the time of reporting the case outcome was unknown.Sender comment: based on the known safety profile, when used according to label (this case olu), company causality is considered not related to euflexxa for the 'seronegative spondyloarthropathy' event as there is no clinical evidence.Overall listedness (core label) is unlisted.Reporter causality: related company causality: related other case numbers: internal # - others = us21-01372.

• 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
• MDR Report Key: 16439016
• MDR Text Key: 310259621
• Report Number: 0002244564-2021-00014
• 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: Physician
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female