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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIDIA FARMACEUTICI SPA HYALGAN PFS ACID, HYALURONIC, INTRAARTICULAR

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FIDIA FARMACEUTICI SPA HYALGAN PFS ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number E16670
Device Problems Inaccurate Delivery (2339); Misfire (2532)
Patient Problem Insufficient Information (4580)
Event Date 10/28/2021
Event Type  malfunction  
Event Description
Spontaneous call from md office spoke to (b)(6) rn: upon injection hyalgan, md reports "misfire" of syringe. Only able to dispense part of the medication. No other information available. Indication: unilateral primary osteoarthritis, right knee. Reported to (b)(6) by health professional.
 
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Brand NameHYALGAN PFS
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FIDIA FARMACEUTICI SPA
MDR Report Key12728630
MDR Text Key279814964
Report NumberMW5105056
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberE16670
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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