MAUDE Adverse Event Report: IBSA FARMACEUTICI GELSYN-3

Catalog Number	GS3111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the limited information available, no conclusions can be made in regards to the reported event.It was noted that the patient also received an injection of zilretta, however, the timing of the injections are unknown.All of the symptoms could be related to either injection or may be a local reaction to the injection procedure.
Event or Problem Description
It was reported that the patient experienced high blood pressure, dizziness, chills, lack of appetite, and swelling after receiving three rounds of bilateral gelsyn-3 injections.The patient also received zilretta on an unknown date.This is documented in maude under report mw5084046.The patient reported hospitalization and disability/permanent impairment as event outcomes.It was reported that the patient is also on rabeprazole, doxepin, meclizine, ranitidine, mometasone furote ointment, welchol, and zyrtec concomitantly.

• Brand Name: GELSYN-3
• Common Device Name: GELSYN-3
• Manufacturer (Section D): IBSA FARMACEUTICI; via martiri di cefalonia, 2; lodi, 26900 ; IT 26900
• MDR Report Key: 9240859
• Report Number: 3009595577-2019-00003
• Device Sequence Number: 114410
• Product Code: MOZ
• UDI-Device Identifier: 08033638951057
• UDI-Public: 08033638951057
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2018
• Report Date (Section F): 02/08/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: GS3111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/25/2019
• Event Location: Home
• Date Report to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Disability
• Date Report Sent to FDA: 02/08/2019