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

Lot Number F35910

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hot Flashes/Flushes (2153)

Event Date 03/24/2023

Event Type  Injury  

Event Description

This is a case-report received by fidia from an italian specialist physician (orthopedic) on (b)(6) 2023.Initially this case has been assessed by the primary reporter (physician) as a non-serious case-report.According to the follow-up information received on 17 may 2023, the case-report has been updated as serious case-report, because of other medically important condition: continuing discomforts (local feeling of body temperature changes) for about 2 months.On (b)(6) 2023, two injections of hymovis (batch number: f35910) were administered to a 75-year-old male patient to both knees, for arthrosis.Relevant medical history included: arthrosis.On (b)(6) 2023, the patient experienced a sensation of coldness local (in the knees), hot feeling in feet and hot flushes of legs.As a result of these undesirable side-effects, the patient wakes up several times during the night.As a result of the undesirable side-effect experienced, the patients went to his general practitioner who prescribed him nsaids, corticosteroids therapy and the laboratory tests (emg, mri, ultrasound doppler), as in his opinion the device had not administered correctly (outside the intra-articular space).On (b)(6) 2023, the patient informed the orthopedic (primary reporter) about the undesirable side-effects experienced; on the same date, fidia received this case-report from the orthopedic.Up to (b)(6) 2023, the orthopedic informed fidia that the outcome of the occurred undesirable side-effects was not resolved, and that the results of the laboratory tests were negative.Reactions as reported by primary reporter: "cold knee, hot feet and heat in the legs (bilateral).Difficulty sleeping due to discomfort".Concomitant medication was not reported.On 25 may 2023, the investigation results on batch analysis received by fidia manufacturing quality department pointed out that: no quality anomalies were detected from the investigation performed on the production and quality control documentation; so no relation can be associated with the reported incidents.

• Brand Name: HYMOVIS
• 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: giuseppina lo castro ; via ponte della fabbrica 3/a; abano terme, padua 35031 ; IT 35031
• MDR Report Key: 17036888
• MDR Text Key: 316285528
• Report Number: 9610200-2023-00003
• 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: 05/31/2023

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
• Device Operator: Health Professional
• Device Lot Number: F35910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male