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

Catalog Number 89122-0724-20

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Thrombosis (2100)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

Exemption number e2011017.On 28 november 2011, the fda granted the permission for the manufacturer fidia farmaceutici (b)(4) to submit a single mdr for adverse events that involve medical devices manufactured by fidia farmaceutici (b)(4).And imported into the usa by (b)(4).As a consequence, fidia farmaceutici (b)(4) (the manufacturer) is submitting this report even on behalf of (b)(4) (the importer).The present mdr report satisfies the reporting obligations for both companies.Fidia received this case report from fda us health authority.The reporter noticed a suspected sensitivity to the medication and a possible deep vein thrombosis.Fidia deemed the relationship of the suspected sensitivity with hyalgan as possible, as reported in the summary of product characteristics.The deep vein thrombosis (dvt) is not clearly documented neither by instrumental tests nor by identified clinical symptoms and signs.So, the relationship between the dvt and hyalgan administration is doubt.We proceed with the notification to the european health authorities via (b)(4) with a report comprehensive of the initial and follow up informations.The submission of the mdr to the fda via gateway will be performed by the 7th of september.The case will be sent to the commercial partners.This report was resubmitted as initial report on 07-may-2020, following the request by fda.The initial report have been erroneously submitted as follow-up on 29-aug-2017.The previously information sent have not been changed.

Event Description

Initial and follow up information have been processed together.This case was sent to fda by (b)(6) pharmacy on (b)(6) 2017 and it was received by fda on 07-jul-2017.The date fda added the report was 12-jul-2017.Fda sent in turn the case report (reference number mw5070920) to fidia pharma usa inc., on 20-jul-2017.Fidia pharma usa inc received the case report on 08-aug-2017.An unknown patient received hyalgan injection on (b)(6) 2017.A pharmacist of (b)(6) pharmacy reported that the patient experienced a serious injury.According to the report, the patient stated that the physician discontinued the hyalgan due to a suspected sensitivity (swelling, pain and tenderness) to the 'medication' (product) and possible deep vein thrombosis.The dose or amount: 20mg; frequency: once weekly, routine ia.No further information was available.Fidia pharma usa inc emailed the initial reporter, (b)(6) pharmacy product safety, on (b)(6) 2017 for information in order to investigate this case.Follow up: 11-aug-2017: updates include patient gender, date of birth, patient identifier, and that the event abated after use stopped.A (b)(6) female patient received hyalgan injection on (b)(6) 2017.(b)(6) pharmacy reported that the patient experienced a serious injury.According to the report the patient stated that the physician discontinued the hyalgan due to a suspected sensitivity (swelling, pain and tenderness) to the 'medication' (product) and possible deep vein thrombosis.It was reported that the event abated after use of the product stopped or was reduced.The patient's medical history and medications are unknown.No contact information has been provided for either the patient or physician.Further investigation is not possible due to lack of information.No other information is available for this case.

• Brand Name: HYALGAN
• Type of Device: SODIUM HYALURONATE
• 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, 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: 6826904
• MDR Text Key: 190179678
• Report Number: 9610200-2017-00005
• 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: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/09/2017,05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 89122-0724-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/08/2017
• Date Report to Manufacturer: 08/09/2017
• Date Manufacturer Received: 08/08/2017
• 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): Other
• Patient Age: 48 YR
• Patient Sex: Female