MAUDE Adverse Event Report: IBSA FARMACEUTICI ITALIA SRL GELSYN-3 ZILRETTA; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Swelling (2091); Chills (2191); Dizziness (2194)

Event Date 12/05/2018

Event Type  Injury  

Event Description

Injection of gelsyn-3 into both knees done 3 times: date (b)(6) 2018, (b)(6) 2018, (b)(6) 2018.Result: blood pressure high, dizziness, chills off and on, lack of appetite, itching, swelling.Injection at medical center.

• Brand Name: GELSYN-3 ZILRETTA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): IBSA FARMACEUTICI ITALIA SRL
• MDR Report Key: 8339466
• MDR Text Key: 136745083
• Report Number: MW5084046
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 88 YR
• Patient Weight: 72