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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

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BAYER HEALTHCARE LLC ESSURE KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE Back to Search Results
Model Number ESS305
Event Type  Death  
Event Description

Underdeveloped lungs in premature baby [immature respiratory system] premature baby (b)(6) [premature baby 26 to 32 weeks]. Case description: serious, related, unlisted (incident, unanticipated). This spontaneous case report was rec'd from a consumer in the united states on (b)(6) 2014 via internet. The report refers to the prematurely ((b)(6) week) born male baby whose mother of unspecified age had essure (fallopian tube occlusion insert) inserted and experienced pregnancy with essure, essure failed, and errant coil perforated the amniotic sac causing her water to break, and mother went into premature labor at (b)(6) weeks. Baby's under-developed lungs could not sustain him and he died on the day he was born. Mother's case was reported at bayer case number (b)(6). No info was given on mother's history, past drugs, concomitant medication and concurrent conditions. On an unspecified date, the mother had essure (fallopian tube occlusion insert) inserted for permanent birth control. On an unspecified date, the mother experienced pregnancy with essure, essure failed, and mother went into premature labor at (b)(6) weeks after an errant coil perforated the amniotic sac causing her water to break. Male baby was born alive, and his under-developed lungs could not sustain him and he died on the day he was born. Reporter assessed the events were related to essure. F/u -ptc investigation result was rec'd on (b)(6) 2014. This adverse event report is related to a product technical complaint (ptc). The bayer reference number for the ptc report is: ptc local number (b)(4) and pyc global number (b)(6). Final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done. No device returned; therefore, no device investigation could be completed. No conclusions can be drawn. Medical assessment: the medical events reported are not necessarily indicative of a quality defect. No complaint sample was provided for a technical investigation. No batch number was reported. Neither a technical batch investigation nor a batch cluster review in gpv database for a more detailed statistical medical evaluation is possible without a batch number. At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect". Based on the info available, there is no reason to suspect a quality defect. F/u (b)(6) 2014: reporter denies further contact. Company causality comment: a spontaneous case of premature baby (b)(6) weeks and underdeveloped lungs in premature baby in a male baby, whose mother went into premature labor at (b)(6) weeks after errant coil perforated the amniotic sac causing her water to break in association with mother;s essure (fallopian tube occlusion insert) use was reported by a consumer. The male baby died on the day he was born. This case was not medically confirmed. Premature baby (b)(6) weeks and its complication underdeveloped lungs in premature baby were regarded serious due to fatal and unlisted for essure in the reference safety info. Given the compatible temporal relationship a contributive effect of dislocated essure in baby's mother to the occurrence of the events in the baby cannot be excluded (related). Both events were regarded as incidents. According to the rec'd ptc (product technical complaint) analysis there is no reason to suspect a quality defect of the product.

 
Manufacturer Narrative

Final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done. No device returned; therefore, no device investigation could be completed. No conclusions can be drawn. Medical assessment: the medical events reported are not necessarily indicative of a quality defect. No complaint sample was provided for a technical investigation. No batch number was reported. Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without a batch number. At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect". Based on the info available, there is no reason to suspect a quality defect.

 
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Brand NameESSURE
Type of DeviceKNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
Manufacturer (Section D)
BAYER HEALTHCARE LLC
milpitas CA
Manufacturer (Section G)
BAYER HEALTHCARE LLC
1011 mccarthy blvd
milpitas CA 95035
Manufacturer Contact
k. lamberson, m.d.
100 bayer boulevard
p.o. box 915
whippany , NJ 07981-0915
MDR Report Key3853615
Report Number2951250-2014-00178
Device Sequence Number1
Product CodeKNH
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 04/29/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberESS305
Is The Reporter A Health Professional? No
Date Manufacturer Received04/29/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/29/2014 Patient Sequence Number: 1
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