MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-23 for HYALGAN 89122-0724-20 manufactured by Fidia Farmaceutici S.p.a..
[145934111]
(b)(4). The case is a spontaneous report by a physician (medically confirmed) received by fidia business partner in (b)(6). A male patient (age unspecified), on unspecified data, was administered in the knee with a single dose of 20mg/2ml of hyalgan solution for injection by intra-articular route for the treatment of gonarthrosis. After unspecified time the patient experienced septic arthritis (joint pain associated with joint swelling at injection site confirmed by the analysis of synovial fluid). The batch number is not available at the moment; so, no evaluation can be performed to fully exclude a drug origin of the septic arthritis. Septic arthritis is an event listed in the ccsi of hyalgan and often related to the injection itself in case of absence of aseptic precautions, rather than to the drug. However, in absence of further information the causal relationship is assessed as possible. The case has been deemed serious due to hospitalization. This case comes from the country (b)(6) in which hyalgan is classified a drug.
Patient Sequence No: 1, Text Type: N, H10
[145934112]
Thi is a spontaneous report received through fidia business partner in (b)(6). It is a medically confirmed case. Initial information received on 24-apr-2019, from a rheumatologist during a seminar. On unspecified date, a male patient (age unspecified), with no specified medical history, received hyalgan 20 mg/2 ml, solution for injection (sodium hyaluronate), in the knee by intra-articular route for gonarthrosis. An unspecified time after the injection, the patient experienced joint pain associated with joint swelling in the injection site. The patient was immediately hospitalized. Septic arthritis was diagnosed. As corrective measure, the patient first received intravenously amoxicilline then orally (no other information provided). After an unspecified date, event resolved and the patient was discharged from hospital. According to the reporting physician, the septic arthritis was not related to hyalgan but to the medical procedure itself. At the time of reporting, the patient had fully recovered from arthritis septic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610200-2019-00006 |
| MDR Report Key | 8635183 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-23 |
| Date Facility Aware | 2019-05-03 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GIUSEPPE DI SANTE |
| Manufacturer Street | VIA PONTE DELLA FABBRICA, 3/A |
| Manufacturer City | ABANO TERME, PADUA 35031 |
| Manufacturer Country | IT |
| Manufacturer Postal | 35031 |
| Manufacturer G1 | FIDIA FARMACEUTICI S.P.A. |
| Manufacturer Street | VIA PONTE DELLA FABBRICA, 3/A |
| Manufacturer City | ABANO TERME, PADUA 35031 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 35031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYALGAN |
| Generic Name | HYALURONATE SODIUM |
| Product Code | MOZ |
| Date Received | 2019-05-23 |
| Catalog Number | 89122-0724-20 |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FIDIA FARMACEUTICI S.P.A. |
| Manufacturer Address | VIA PONTE DELLA FABBRICA, 3/A ABANO TERME, PADUA 35031 IT 35031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-05-23 |