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

Device Problem Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Thyroid Problems (2102); Malaise (2359); Low Oxygen Saturation (2477); Weight Changes (2607)

Event Date 11/05/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The case is of difficult evaluation due to the incomplete information.Fidia farmaceutici received in copy this information on the case by another pharmaceutical company ((b)(4)).Any attemps have been carried out to verify the hyaluronic acid based-product involved in the suspect adrs but any effort was unsuccessful.The consumer didn't want neither to give further information nor the permission to contact her physician.Conservatevely the case has been submitted to the fda considering the ae as if it was occurred with fidia's product (hyalgan).The relationship of hyalgan with the hypertension, oxygen desaturation and sickness was deemed possible according to a temporal algorithm.The relationship of hyalgan with the thyroidectomy and the weight gain is deemed for both unassessable due to the paucity of the information.The case is notified late due to the technical problems during the test phase for the electronic submission as webtrader.The device is not available.

Event Description

This spontaneous, serious adverse event was reported by a (b)(6) female patient via another pharmaceutical company's patient support program.On an unknown date the patient received unknown hyaluronic gel injections of an unknown dose and frequency into her knees for an unknown indication.On 02/sep/2015 the patient reported that she began treatment with lovaza in 2005 for the treatment of high triglycerides.The patient noted her concomitant medications at the time to be synthroid, diclofenac and the unknown hyaluronic gel.The patient reported that on (b)(6) 2014 she underwent a partial thyroidectomy and subsequently gained 22 pounds.On (b)(6) 2015 the patient got sick and on (b)(6) 2015 she presented to the emergency room.The patient's blood pressure was so high it was to a stroke level and her oxygen saturation dropped.The lot number and expiration date of the unknown hyaluronic acid gel injections are unknown.As of (b)(6) 2015 it was unknown whether the patient continued to receive the unknown hyaluronic acid gel injections and the outcome of thyroidectomy, weight gain, sickness, blood pressure high at stroke level, and oxygen saturation decreased was unknown.The patient reported that these events had nothing to do with lovaza though she was not taking as much as she should, but could be a result of a combination of medications that she received including synthroid, diclofenac, and hyaluraonic gel injected into her knees.The patient denied authorization to contact her physician and requested to not be contacted again.

• Brand Name: HYALURONIC ACID
• Type of Device: INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3a; abano terme, padua 35031 ; IT 35031
• Manufacturer (Section G): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3a; abano terme, padua 35031 ; IT 35031
• Manufacturer Contact: giuseppe di sante ; via ponte della fabbrica , 3/a; abano terme, padua 35031 ; IT 35031 ; 8232827
• MDR Report Key: 5506551
• MDR Text Key: 40535816
• Report Number: 9610200-2015-00007
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P950027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 11/18/2015,03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/12/2015
• Event Location: Home
• Date Report to Manufacturer: 11/18/2015
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: LEVOTHYROXINE (SYNTHROID)
• Patient Outcome(s): Other
• Patient Age: 63 YR