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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IBSA FARMACEUTICI ITALIA SRL/IBSA PHARMA INC. GELSYN - 3 INJ 16.8/2 ML ACID, HYALURONIC, INTRAARTICULAR

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IBSA FARMACEUTICI ITALIA SRL/IBSA PHARMA INC. GELSYN - 3 INJ 16.8/2 ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 10/11/2019
Event Type  Injury  
Event Description
Per (b)(6) using gelsyn 3 for both knee and shoulder is common practice for their office.
 
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Brand NameGELSYN - 3 INJ 16.8/2 ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
IBSA FARMACEUTICI ITALIA SRL/IBSA PHARMA INC.
MDR Report Key9202999
MDR Text Key162886056
Report NumberMW5090444
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 10/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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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