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

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577)

Event Date 05/06/2022

Event Type  Injury  

Event 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 Description

There has been no event updates.

• Brand Name: GELSYN
• Type of Device: HYALURONIC ACID
• Manufacturer (Section D): IBSA FARMACEUTICI ITALIA SRL; via martiri di cefalonia; lodi, 2-269 00; IT 2-26900
• MDR Report Key: 14800611
• MDR Text Key: 295059016
• Report Number: 3009595577-2022-00001
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 08033638951057
• UDI-Public: (01)08033638951057(10)2109079(17)240930
• 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,Followup
• Report Date: 06/24/2022,07/01/2022

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
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 06/24/2022
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female