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U.S. Department of Health and Human Services

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

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FIDIA FARMACEUTICI S.P.A. HYALGAN SODIUM HYALURONATE Back to Search Results
Catalog Number 89122-0724-20
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Thrombosis (2100)
Event Date 07/05/2017
Event Type  Injury  
Manufacturer Narrative
Exemption number e2011017. On 28 november 2011, the fda granted the permission for the manufacturer fidia farmaceutici (b)(4) to submit a single mdr for adverse events that involve medical devices manufactured by fidia farmaceutici (b)(4). And imported into the usa by (b)(4). As a consequence, fidia farmaceutici (b)(4) (the manufacturer) is submitting this report even on behalf of (b)(4) (the importer). The present mdr report satisfies the reporting obligations for both companies. Fidia received this case report from fda us health authority. The reporter noticed a suspected sensitivity to the medication and a possible deep vein thrombosis. Fidia deemed the relationship of the suspected sensitivity with hyalgan as possible, as reported in the summary of product characteristics. The deep vein thrombosis (dvt) is not clearly documented neither by instrumental tests nor by identified clinical symptoms and signs. So, the relationship between the dvt and hyalgan administration is doubt. We proceed with the notification to the european health authorities via (b)(4) with a report comprehensive of the initial and follow up informations. The submission of the mdr to the fda via gateway will be performed by the 7th of september. The case will be sent to the commercial partners. This report was resubmitted as initial report on 07-may-2020, following the request by fda. The initial report have been erroneously submitted as follow-up on 29-aug-2017. The previously information sent have not been changed.
 
Event Description
Initial and follow up information have been processed together. This case was sent to fda by (b)(6) pharmacy on (b)(6) 2017 and it was received by fda on 07-jul-2017. The date fda added the report was 12-jul-2017. Fda sent in turn the case report (reference number mw5070920) to fidia pharma usa inc. , on 20-jul-2017. Fidia pharma usa inc received the case report on 08-aug-2017. An unknown patient received hyalgan injection on (b)(6) 2017. A pharmacist of (b)(6) pharmacy reported that the patient experienced a serious injury. According to the report, the patient stated that the physician discontinued the hyalgan due to a suspected sensitivity (swelling, pain and tenderness) to the 'medication' (product) and possible deep vein thrombosis. The dose or amount: 20mg; frequency: once weekly, routine ia. No further information was available. Fidia pharma usa inc emailed the initial reporter, (b)(6) pharmacy product safety, on (b)(6) 2017 for information in order to investigate this case. Follow up: 11-aug-2017: updates include patient gender, date of birth, patient identifier, and that the event abated after use stopped. A (b)(6) female patient received hyalgan injection on (b)(6) 2017. (b)(6) pharmacy reported that the patient experienced a serious injury. According to the report the patient stated that the physician discontinued the hyalgan due to a suspected sensitivity (swelling, pain and tenderness) to the 'medication' (product) and possible deep vein thrombosis. It was reported that the event abated after use of the product stopped or was reduced. The patient's medical history and medications are unknown. No contact information has been provided for either the patient or physician. Further investigation is not possible due to lack of information. No other information is available for this case.
 
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Brand NameHYALGAN
Type of DeviceSODIUM HYALURONATE
Manufacturer (Section D)
FIDIA FARMACEUTICI S.P.A.
via ponte della fabbrica, 3a
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 Key6826904
MDR Text Key190179678
Report Number9610200-2017-00005
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P950027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 08/09/2017,05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number89122-0724-20
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/08/2017
Event Location No Information
Date Report to Manufacturer08/09/2017
Date Manufacturer Received08/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/29/2017 Patient Sequence Number: 1
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