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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL FEMOSTOP CLAMP, VASCULAR Back to Search Results
Device Problems Defective Device (2588); Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 02/28/2022
Event Type  malfunction  
Event Description
New fem stop placed 1st one not working. Multiple fem stops placed. Two (2) of the femostop had eo5 code and was not working; 4th femostop finally placed and working.
 
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Brand NameFEMOSTOP
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key13938726
MDR Text Key288197116
Report NumberMW5108576
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/25/2022
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received03/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes

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