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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER ESSURE
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BAYER ESSURE Back to Search Results
Device Problem Malposition of Device (2616)
Patient Problems Pulmonary Embolism (1498); Death (1802); Hair Loss (1877); Pain (1994); Skin Irritation (2076); Hernia (2240)
Event Date 01/18/2015
Event Type  Death  
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Brand Name
ESSURE
Manufacturer (Section D)
BAYER
MDR Report Key4569275
Report NumberMW5041064
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Source Type Invalid Data
Reporter Occupation Patient
Type of Report Initial
Report Date 01/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Is the Reporter a Health Professional? No
Patient Sequence Number1
Patient Outcome(s) Death;
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