MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYALGAN; INTRA-ARTICULAR INJECTION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Fever (1858); Respiratory Tract Infection (2420); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The present mdr report satisfies the reporting obligations for both companies.The case was received from fidia pharma usa (the fidia's partner in usa).The adverse events "atrial fibrillation, breath shortness, infection respiratory, fever and sputum" are unexpected for hyalgan.The case has been classified as "serious" due to the hospitalization of the patient.Therefore, the case has been classified as serious/unexpected.The patient reported that his physician does not believe these symptoms are related to hyalgan and after the follow-up information of the case, the patient noted that the events are not related to hyalgan, so the relationship between hyalgan and the events was deemed as being "not related".Device was not available.

Event Description

This spontaneous, serious adverse event was reported by a (b)(6)-year-old male patient.In (b)(6) 2016 the patient began hyalgan, 5 injections in the right knee, at an unknown frequency for osteoarthritis.The patient finished hyalgan injections 2-3 weeks ago.One week after his last injection, he experienced worsening of congestive heart failure described as atrial fibrillation.The patient reported that his physician does not believe these symptoms are related to hyalgan.The patient has an appointment with a cardiologist in (b)(6) 2016 to address the atrial fibrillation.The patient reported that he also experienced shortness of breath just sitting in a chair.The patient went to the hospital and was admitted for respiratory infection, fever of 101, and coughing up sputum.The patient remains in the hospital and is being treated with antibiotics.The lot number and expiration date are unknown.As of (b)(6) 2016, the patient had completed his series of hyalgan and was no longer using it.The outcome of atrial fibrillation is ongoing.The outcome of shortness of breath, respiratory infection, fever, and coughing up sputum are unknown.Follow-up 21-sep-2016: this consumer reports that he had a history of stage 4 congestive heart failure (chf) 3 years ago which was treated and the severity was reduced to stage 2 and he was living somewhat of a normal life, he had a heart attack in 2011 and a heart attack in 2012, and a pacemaker placement.His relevant past drug history includes experiencing worsening chf to stage 4 within 2 weeks after a shingles vaccine in 2013.Three weeks ago after completing his fifth of the 5 hyalgan injections, his congestive heart failure worsened, which primarily manifested as shortness of breath.His pacemaker communicated with the clinic that he was in atrial fibrillation.Ten days ago, he got a bad cold.Last week, he was in the hospital for a respiratory problem, atrial fibrillation and heart failure.He was treated with antibiotics and steroids while in hospital.On (b)(6) 2016, they put him under sedation and caused his pacemaker to shock his heart out of atrial fibrillation and this worked.He was discharged.He states that he is not saying that these events are related to hyalgan.As of (b)(6) 2016, he is no longer taking hyalgan and the atrial fibrillation and fever have resolved.The respiratory infection, shortness of breath, coughing up sputum, and cold are better.

• Brand Name: HYALGAN
• Type of Device: INTRA-ARTICULAR INJECTION
• 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 ; 0498232827
• MDR Report Key: 6014052
• MDR Text Key: 57103405
• Report Number: 9610200-2016-00010
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/14/2016,10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2016
• Date Report to Manufacturer: 09/14/2016
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR