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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Conjunctivitis (1784); Rash (2033); Ulceration (2116); No Code Available (3191)

Event Date 03/25/2006

Event Type  Injury  

Manufacturer Narrative

(b)(4).The case comes from literature/(b)(6) (country: (b)(6)).A patient after the use of a product containing hyaluronate sodium as active substance had: hepatic enzymes increased, buccal ulceration, pruritus, drug rash with eosinophilia and systemic symptoms (dress syndrome), conjunctivitis, creatinine blood increased, exanthema.The case has been deemed as serious by the reporter due to hospitalization.The case has been deemed as serious/expected for pruritus and exanthema and deemed as serious/unexpected for the other aes.All the aes could be related to dress syndrome due to a drug exposure.The causality relationship has been evaluated as possible by the company, as the reactions may have been produced by other therapeutic interventions on the patient.No new signal alert has been detected.No additional information is required to perform this medical evaluation from the pv physician.This case comes from the country (b)(6) in which fidia's product containing hyaluronate sodium is classified a drug.

Event Description

This is a spontaneous report by a physician, downloaded by fidia from (b)(6) on 04-feb-2019 (worldwide number: (b)(4)).This case was retrieved from jonville-bera ap, la gastine b, le beller c et al.Dress syndrome associated with strontium ranelate.Fund clin pharmacol.2008; 22 (suppl 1): 54; mardivirin l, valeyrie-allanore l, branlant-redon e et al.Amoxicillin-induced flare in patients with dress (drug reaction with eosinophilia and systemic symptoms): report of seven cases and demonstration of a direct effect of amoxicillin on human herpesvirus 6 replication in vitro.Eur j dermatol.2010; 20: 68-73.It is a medically confirmed case.A (b)(6) female patient was treated with: hyaluronate sodium (mah unknown), by intra-articular route, at the dose of 1 df for 3 times from (b)(6) 2006 to (b)(6) 2006, for arthrosis; ideos (cholecalciferol, calcium carbonate), by oral route, at an unknown dose, from (b)(6) 2006 to (b)(6) 2006, for unknown indication; protelos granules for oral suspension (strontium ranelate), by oral route, at an unknown dose, from (b)(6) 2006 to (b)(6) 2006, for unknown indication.The patient experienced: on (b)(6) 2006, hepatic enzymes increased, buccal ulceration, pruritus, drug rash with eosinophilia and systemic syndrome, creatinine blood increased, exanthema; on (b)(6) 2006, conjunctivitis.The events were reported as serious due to hospitalization.Ideos and protelos were withdrawn.At the time of the reporting, the events were resolved.Concomitant medications: dafalgan (paracetamol), unknown pharmaceutical form, by oral route, unknown dose, from (b)(6) 2005; art 50 (diacerein), unknown pharmaceutical form, by oral route, unknown dose, from (b)(6) 2005; mobic (meloxicam), unknown pharmaceutical form, by oral route, unknown dose, from (b)(6) 2006 to (b)(6) 2006; ketum (ketoprofen), unknown pharmaceutical form, unknown dose, from (b)(6) 2005; clamoxyl /net/ (amoxicillin trihydrate), unknown pharmaceutical form, by oral route, unknown dose, from (b)(6) 2006, for tonsillitis; lanzor (lansoprazole), unknown pharmaceutical form, by oral route, unknown dose, from (b)(6) 2006 to (b)(6) 2006.

• Brand Name: HYALURONATE SODIUM
• 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: giuseppe di sante ; via ponte della fabbrica, 3/a; abano terme, padua 35031 ; IT 35031
• MDR Report Key: 8377054
• MDR Text Key: 137382396
• Report Number: 9610200-2019-00001
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Type of Report: Initial
• Report Date: 02/28/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/05/2019
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ART 50 (DIACEREIN); CLAMOXYL /NET/ (AMOXICILLIN TRIHYDRATE); DAFALGAN (PARACETAMOL); KETUM (KETOPROFEN); LANZOR (LANSOPRAZOLE); MOBIC (MELOXICAM)
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR