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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER HEALTHCARE LLCESSUREDEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

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BAYER HEALTHCARE LLC ESSURE DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE   Back to Search Results
Model Number ESS305
Event Date 08/26/2013
Event Type  Death   Patient Outcome  Death,Required Intervention
Event Description

Patient had essure procedure (b)(6) 2013. Physician placed on essure device in patient's right and left fallopian tube. On (b)(6) 2013 patient went to emergency room with abdominal pain. Dr (b)(6) (who was not the implant doctor) performed a pelvic exam found the patient's cervix, fallopian tubes and uterus were necrotic. Patient had blood cultures, patient tested positive for group a strep infection. On (b)(6) 2013, patient went into renal failure and dic, patient passed way. On (b)(6) 2013, dr (b)(6) stated blood cultures were positive for group a strep and he believes the cause of death was related to necrotizing group a streptococcus infection (streptococcal toxic shock syndrome).

 
Manufacturer Narrative

The medical opinion of the attending physician was that the cause of death was not directly related to the essure inserts or procedure.

 
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Brand NameESSURE
Type of DeviceDEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
Manufacturer (Section F)
BAYER HEALTHCARE LLC
milpitas CA
Manufacturer (Section D)
BAYER HEALTHCARE LLC
milpitas CA
Manufacturer Contact
michael reddick
1011 mccarthy blvd
milpitas , CA 95035
(650) 962 -4238
Device Event Key3399978
MDR Report Key3369777
Event Key3266372
Report Number2951250-2013-00017
Device Sequence Number1
Product CodeKNH
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/18/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberESS305
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/26/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

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