MAUDE Adverse Event Report: BIOVENTUS / IBSA FARMACEUTICI ITALIA SRL GELSYN-3 PFS 16.8MG/2ML; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

Gelsyn indication: bilateral primary osteoarthritis of knee.Patient reported there was a hospitalization, and the patient will notify the specialist about the visit.Unknown reason, dates or length of stay of hospitalization.No other information provided.Dose or amount: 16.8mg weekly for 3 weeks, intra-articularly.Dates of use: (b)(6) 2022 to unk.Reported to (b)(6) by pt/caregiver.

• Brand Name: GELSYN-3 PFS 16.8MG/2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS / IBSA FARMACEUTICI ITALIA SRL
• MDR Report Key: 15224259
• MDR Text Key: 297948598
• Report Number: MW5111461
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2022

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: 08/12/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male