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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 Name
FEMOSTOP
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key13938726
MDR Text Key288197116
Report NumberMW5108576
Device Sequence Number3
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 Nurse
Type of Report Initial
Report Date 03/25/2022
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient Age67 YR
Patient SexFemale
Patient Weight68 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
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