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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIDIA FARMACEUTICI SPA HYALGAN SODIUM HYLAURONATE PRE-FILLED SYRINGE - 2ML ACID, HYALURONIC, INTRAARTICULAR

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FIDIA FARMACEUTICI SPA HYALGAN SODIUM HYLAURONATE PRE-FILLED SYRINGE - 2ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Model Number 72420
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Date 04/19/2019
Event Type  malfunction  
Event Description
Luer lock disconnected from syringe of prepackaged/prefilled hyalgan (sodium hyaluronate).
 
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Brand NameHYALGAN SODIUM HYLAURONATE PRE-FILLED SYRINGE - 2ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FIDIA FARMACEUTICI SPA
100 campus drive, suite 105
florham park NJ 07932
MDR Report Key8623347
MDR Text Key145491718
Report Number8623347
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72420
Device Lot NumberB13550
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/23/2019
Event Location Other
Date Report to Manufacturer05/20/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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