MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYALGAN; SODIUM HYALURONATE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anaphylactic Shock (1703); Presyncope (4410)

Event Date 04/24/2023

Event Type  Injury  

Event Description

This is a serious case downloaded from eudravigilance on 08-may-2023 (authority number (b)(4)); reported by consumer.On 24-apr-2023 a 46 year-old female patient started hyalgan (sodium hyaluronate).Relevant medical history included multiple allergies (ongoing) to nickel, cobalt, palladium, thiomersal, bee venom.Reactions: on (b)(6) 2023 the patient developed exanthema generalised.The outcome of the event was reported to be recovered/resolved.No actions were taken regarding the event.According to the reporter the event was life-threatening.On (b)(6) 2023 the patient developed oedema larynx.The outcome of the event was reported to be recovered/resolved.No actions were taken regarding the event.According to the reporter the event was life-threatening.On (b)(6) 2023 the patient developed pre-syncope.The outcome of the event was reported to be recovered/resolved.No actions were taken regarding the event.According to the reporter the event was life-threatening.On (b)(6) 2023 the patient developed anaphylactic reaction.The outcome of the event was reported to be recovered/resolved.No actions were taken regarding the event.According to the reporter the event was life-threatening.Reactions as reported by primary source: exanthema generalised, oedema larynx, pre-syncope, anaphylactic reaction.No further information is available.

• Brand Name: HYALGAN
• Type of Device: SODIUM HYALURONATE
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer (Section G): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica 3/a; abano terme, padua 35031 ; IT 35031
• Manufacturer Contact: giuseppina lo castro ; via ponte della fabbrica 3/a; abano terme, padua 35031 ; IT 35031
• MDR Report Key: 17036892
• MDR Text Key: 316383781
• Report Number: 9610200-2023-00005
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 46 YR
• Patient Sex: Female