MAUDE Adverse Event Report: IBSA FARMACEUTICI ITALIA SRL GELSYN-3; SODIUM HYALURONATE FOR INJECTION

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anaphylactoid / Anaphylaxis (2218)
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous serious report received from a physician by bioventus (ref.(b)(4)) on (b)(6) 2019 and merged with the follow-up information received on 07nov2019 through the sales rep.Describes the occurrence of anaphylactic shock, in a patient who was prescribed gelsyn-3 (hyaluronate sodium 0.84 %) injection, for unknown indication.On (b)(6) a (b)(6) male patient received a gelsyn injection (batch n.Na) in the right knee.Several days later (on an unknown date), he experienced an anaphylactic shock.The patient was seen at the emergency room for episode of anaphylaxis, that resolved immediately after the er treatment.No concomitant drugs were reported.Prior use of supartz (hyaluronic acid) last year with no issues noted.Medication change due to insurance.Medical history: prostate, high blood pressure.The patient's allergist stated it could have/may have been related to injection.Ibsa comment: anaphylactic shock is a serious condition.Follow-up clarified that the patient went to the emergency room where he received an appropriate treatment, so the adverse event has been medically confirmed.The case is evaluated as serious (medically significant), unlisted and unlikely related because the reaction occurred few days after the injection.

• Brand Name: GELSYN-3
• Common Device Name: SODIUM HYALURONATE FOR INJECTION
• Manufacturer (Section D): IBSA FARMACEUTICI ITALIA SRL; via martiri di cefalonia 2; lodi (san grato) 26900, it, 26900 ; IT 26900
• MDR Report Key: 9329277
• Report Number: 3008280916-2019-01318
• Device Sequence Number: 11323656
• Product Code: MOZ
• UDI-Device Identifier: 08033638951057
• UDI-Public: 08033638951057
• Combination Product (Y/N): N
• PMA/510(K) Number: P110005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/15/2019
• 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: Other
• Patient Age: 67 YR