MAUDE Adverse Event Report: IBSA FARMACEUTICI ITALIA SRL GELSYN; HYALURONIC ACID

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the patient, 4 days after receiving a gelsyn injection the patient was hospitalized for an infection and treated with iv antibiotics.The patient had two previous gelsyn injections with no adverse events reported.After receiving the third injection the patient reported swelling and pain immediately following the injection.The patient indicated they were unable to walk or raise their left leg.Patient has severe osteoathritis in their left knee.The patient was released from the hospital in stable condition and prescribed antibiotics for 6 weeks.
Event or Problem Description
There has been no event updates.

• Brand Name: GELSYN
• Common Device Name: HYALURONIC ACID
• Manufacturer (Section D): IBSA FARMACEUTICI ITALIA SRL; via martiri di cefalonia; lodi, 2-269 00; IT 2-26900
• MDR Report Key: 14800611
• Report Number: 3009595577-2022-00001
• Device Sequence Number: 20044743
• Product Code: MOZ
• UDI-Device Identifier: 08033638951057
• UDI-Public: (01)08033638951057(10)2109079(17)240930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022
• Report Date (Section F): 06/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: GS3111
• Device Lot Number: 2109079
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/26/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/07/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/24/2022