MAUDE Adverse Event Report: IBSA FARMACEUTICI GELSYN-3

Catalog Number GS3111

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

Patient Problem Reaction (2414)

Event Date 12/05/2018

Event Type  Injury  

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 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
• Type of Device: GELSYN-3
• Manufacturer (Section D): IBSA FARMACEUTICI; via martiri di cefalonia, 2; lodi, 26900 ; IT 26900
• MDR Report Key: 9240859
• MDR Text Key: 177174501
• Report Number: 3009595577-2019-00003
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 08033638951057
• UDI-Public: 08033638951057
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/08/2019,10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GS3111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2019
• Distributor Facility Aware Date: 09/25/2019
• Event Location: Home
• Date Report to Manufacturer: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability