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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FEMOSTOP CLAMP, VASCULAR

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ST. JUDE MEDICAL, INC. FEMOSTOP CLAMP, VASCULAR Back to Search Results
Model Number GOLD
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/15/2019
Event Type  malfunction  
Event Description
The device would not pump to allow for pressure to be applied to site where bleeding was occurring.
 
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Brand NameFEMOSTOP
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
5050 nathan lane north
plymouth MN 55442
MDR Report Key9295203
MDR Text Key165640795
Report Number9295203
Device Sequence Number1
Product Code DXC
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,Followup
Report Date 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGOLD
Device Catalogue NumberC11165
Device Lot Number6587848
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/18/2019
Event Location Hospital
Date Report to Manufacturer11/08/2019
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

Patient Treatment Data
Date Received: 11/08/2019 Patient Sequence Number: 1
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