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

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

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

A female patient used hymovis (hyaluronate sodium hexadecylamide) gel for injection, at the dose of 1 infiltration, via intra-articular route, for unknown indication.4 days after the infiltration, the patient was hospitalized for dvt.At the time of the reporting the outcome was unknown no concomitant medication was reported.Medical history was not reported.No further information is available.

• Brand Name: HYMOVIS
• Type of Device: HYALURONATE SODIUM HEXADECYLAMIDE
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A; via ponte della fabbrica 3/a; abano terme, 35031 ; IT 35031
• Manufacturer Contact: giuseppe di sante ; via ponte della fabbrica 3/a; abano terme, padua 35031 ; IT 35031
• MDR Report Key: 13058454
• MDR Text Key: 282702733
• Report Number: 9610200-2021-00005
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female