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

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

Patient Problems Fatigue (1849); Fever (1858); Headache (1880); Pain (1994); Dizziness (2194)

Event Date 02/28/2019

Event Type  Injury  

Event Description

Patient had first gel-syn injection on (b)(6) 2019.Patient said she was very tired the rest of the day and went to bed early.The next day she was still very tired and felt ¿off¿.The patient described this as aches and pains, flu symptoms.Fever that went up to 99.9 degrees f, extreme headache, and dizziness.The patient tried to get in touch with her doctor, but they haven¿t called her back.The patient feels better now and fever is gone.Patient says she still feels like she doesn¿t have very much energy.Patient said she should hear back from her doctor today.

• Brand Name: GELSYN-3 INJ 16.8/2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): IBSA FARMACEUTICI ITALIA SRL
• MDR Report Key: 8403471
• MDR Text Key: 138377424
• Report Number: MW5084753
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130311101
• UDI-Public: 89130311101
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/04/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR