MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA SYR (3X2ML); ACID, HYALURONIC, INTRAARTICULAR

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Patient's daughter reported patient not being able to take medication due to reaction in (b)(6) 2023.Reported patient broke out in hives and had to go to hospital for it.She could not complete treatment.Hospitalization dates/length of stay are unknown.Date of last dose is unknown.Unknown if specialist is aware no further information.Frequency: once weekly for 3 weeks.Reported to (b)(6) by: patient/caregiver.

• Brand Name: EUFLEXXA SYR (3X2ML)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC. / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 18858129
• MDR Text Key: 337367174
• Report Number: MW5152460
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03/06/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female