MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD EUFLEXXA 1% 20MG/2ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Hyperglycemia (1905)

Event Type  Injury  

Event Description

Hypertension and chest pains.Received a call from (b)(6) at dr.(b)(6) office (b)(6).Patient received a dose of euflexxa syringes on (b)(6) 2022.That evening she experienced hypertension and chest pains.She proceeded to er and a few days later followed up with cardiologist who felt the episode was due to the euflexxa and asked her to discontinue.

• Brand Name: EUFLEXXA 1% 20MG/2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD
• MDR Report Key: 15138229
• MDR Text Key: 297066893
• Report Number: MW5111201
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566-4100-01
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/28/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2022
• Patient Sequence Number: 1
• Treatment: CELEBREX ; CLARITIN ; SYNTHROID
• Patient Age: 51 YR
• Patient Sex: Female