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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); Fever (1858); Pain (1994); Sepsis (2067); Arthralgia (2355); Malaise (2359); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

A (b)(6)-year-old male patient used hymovis (hyaluronate sodium hexadecylamide) via intra-articular route, at the dose of 1 injection in the right knee, on (b)(6) 2020.The injection was performed without the precautions to avoid a bacterial infection (gloves, sterile gown, mask, etc).After a few days, the patient experienced injection site joint pain, injection site joint swelling, fever and general malaise.On (b)(6) 2020 the patient was hospitalized for arthritis septic.Arthritis septic caused him considerable biological damage, temporary disability and permanent disability.At the time of the reporting the outcome was unknown.Reaction as described by the primary source: within a few days of hymovis injection, the patient experienced pain, swelling, high fever and general malaise; during his hospital stay, he is diagnosed with septic arthritis of the knee.Concomitant medication was not reported.No medical history was reported.No further information is available.

• Brand Name: HYMOVIS
• Type of Device: SODIUM HYALURONATE
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica 3/a; abano terme, 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: 12014637
• MDR Text Key: 256710094
• Report Number: 9610200-2021-00003
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 21 YR