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 Pain (1994); Caustic/Chemical Burns (2549); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Chemical burn on right knee following injection [chemical burn].Took euflexxa for pain and swelling [off label use in unapproved indication] [off label use].Case narrative: this serious spontaneous case received from a consumer in united states.This report concerns a 70-year-old female who experienced a chemical burn on right knee following injection and she took euflexxa for pain and swelling [off label use in unapproved indication] during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, route, and frequency, for pain and swelling from (b)(6) 2022 to an unknown stop date.The patient reported she received her first euflexxa injection, for pain and swelling, in her right knee on (b)(6) 2022.The patient stated they put an ice pack on her knee at the physician's office and removed it when she arrived home.When the patient woke up the next morning ((b)(6) 2022), it looked like a chemical burn, she spoke to her physician, and then went to the emergency room (er).The patient saw her physician two weeks later and the chemical burn had not resolved.The patient was unable to provide the lot number and expiration date as it was not given to her.The chemical burn on right knee following injection was medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of took euflexxa for pain and swelling [off label use in unapproved indication], was unknown.The outcome of chemical burn on right knee following injection was recovering/resolving.No concomitant medication was reported.The event chemical burn on right knee following injection was reported as serious.The event took euflexxa for pain and swelling [off label use in unapproved indication] was reported as non-serious.At the time of reporting the case outcome was unknown.Sender comment: due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the 'chemical burn' event as there is no clinical evidence, but might most likely be related to the injection procedure.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal #: (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
• MDR Report Key: 16485951
• MDR Text Key: 310785438
• Report Number: 0002244564-2022-00034
• 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: Other
• Type of Report: Initial
• Report Date: 03/06/2023

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
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female