MAUDE Adverse Event Report: FERRING / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Inflammation (1932); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Patient had second hip replacement (b)(6) 2021, diagnosed with crps, chronic regional pain syndrome, (b)(6) 2021 bladder and kidney inflammation after both covid vaccine (pfizer) first required hospitalization to relieve pressure and stones.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 12737846
• MDR Text Key: 279817214
• Report Number: MW5105059
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 5566410001
• UDI-Public: 5566-4100-01
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/29/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other