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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYALURONIC ACID SODIUM HYALURONATE

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FIDIA FARMACEUTICI S.P.A. HYALURONIC ACID SODIUM HYALURONATE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Diarrhea (1811); Dyspnea (1816); Fatigue (1849); Headache (1880); Nausea (1970); Pain (1994); Blurred Vision (2137); Sneezing (2251); Sore Throat (2396); Reaction, Injection Site (2442); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). The case comes from (b)(6) (country : (b)(6)). A patient, after the use of a product containing hyaluronic acid, had: diarrhea, somnolence, inflammatory bowel disease, difficulty in walking, headache, sty, injection site pain, nausea, blurred vision, sore throat, sneezing, cardiac pain, pain in hip, shortness of breath and fatigue. The case has been deemed as serious by the reporter due to a medical important event. The case has been deemed as serious/unexpected except for injection site pain and pain in hip deemed as serious/expected. The causality relationship has been evaluated as remote by the company as these events can be explained by other therapeutic interventions on the patient (e. G. Ultravist injection and xylocain) and can be explained by the clinical state of the patient (inflammatory bowel disease), except for injection site pain and pain in hip that have been evaluated as probable. No new signal alert has been detected. No additional information is required to perform this medical evaluation from the pv physician.
 
Event Description
This is a spontaneous report by a consumer, downloaded by (b)(4) from (b)(6) on 18-feb-2019 (worldwide number: (b)(4)). Follow-up information was downloaded on 25-feb-2019. Initial and follow-up information is reported together. It is not a medically confirmed case. A (b)(6) female patient was treated with hyaluronic acid (mah unknown), unknown dose and unknown pharmaceutical form, from 2012, for osteoarthritis, and with ultravist solution for injection (iopromide), once in total, from (b)(6) 2018, for x-ray of pelvis and hip. In (b)(6) 2018, the patient experienced: difficulty in walking; pain in hip; shortness of breath; injection site pain; nausea; headache; inflammatory bowel disease; fatigue; cardiac pain; sore throat; diarrhoea; sneezing; blurred vision; sty; somnolence. The events were reported as serious due to medically important condition. At the time of the reporting, the outcome was unknown. Reaction as described by the primary source: difficulties to walk for two months; pain in hip worsening, persistant pains in hip; shortness of breath, difficulties to breath; acute right hip pain just after injection; nausea, transit disorder nausea and diarrhoea-like; headaches; inflammatory bowel disease worsened since ultravist injection; big fatigue; little pain in heart; sore throat; diarrhoea, transit disorder nausea and diarrhoea-like; a lot of sneezing; blurred vision; sty; somnolence. Patient past drug history: xylocain (lidocaine hydrochloride). Concomitant medications: doliprane (paracetamol), unknown dose, entocort (budesonide) at the dose of 6 mg, qd. No further information was available.
 
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Brand NameHYALURONIC ACID
Type of DeviceSODIUM 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
giuseppe di sante
via ponte della fabbrica, 3/a
abano terme, padua 35031
IT   35031
MDR Report Key8424535
MDR Text Key138922413
Report Number9610200-2019-00003
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/21/2019
Event Location No Information
Date Manufacturer Received02/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/15/2019 Patient Sequence Number: 1
Treatment
DOLIPRANE (PARACETAMOL); ENTOCORT (BUDESONIDE)
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