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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION

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BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION Back to Search Results
Model Number ESS305
Event Type  Injury  
Event Description

This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting taking place in (b)(6) 2015 (case # fda-2015-n-2781-0536, awareness date 14-aug-2015 ). It was received from a female consumer of unspecified age in united states who had essure (fallopian tube occlusion insert) inserted on an unspecified date for birth control. This case refers to consumer's fetus. Consumer reported she had a stillbirth at 4 months pregnancy. For mother's case please refer to case: (b)(4). Company causality comment: this non-medically confirmed, spontaneous case report was received from a female consumer and refers to her fetus; who was exposed to essure (fallopian tube occlusion insert) in uterus. The mother gave birth to the stillborn at (b)(6) months pregnant. The reported event is unlisted according to essure's reference safety information. In this particular case, limited information was provided. Neither the complications experienced by the mother nor fetus status were specified. Nevertheless, considering the event occurred during the second trimester of gestation; a mechanical interference between essure and the developing pregnancy cannot be excluded and the reported death was, thus considered as related to the suspect insert. This case was considered an incident, due to fetal death. A product technical analysis is being sought. No active follow-up will be pursued, as this case was identified during health authority website monitoring.

 
Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

 
Manufacturer Narrative

Product technical complaint (ptc) investigation result received on 22-mar-2016: (b)(4). Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint. Typically, we would inspect the micro-insert to look for any manufacturing deficiencies. Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record. We are unable to confirm any quality defect or device malfunction at this time. There was no event reported which indicates a new technical failure mode for the device. Medical assessment: based on the available information, there is no relationship between the reported events and a quality defect. Company causality comment: this non-medically confirmed, spontaneous case report was received from a female consumer and refers to her fetus; who was exposed to essure (fallopian tube occlusion insert) in uterus. The mother gave birth to the stillborn at (b)(6) pregnant. The reported event is unlisted according to essure's reference safety information. In this particular case, limited information was provided. Neither the complications experienced by the mother nor fetus status were specified. Nevertheless, considering the event occurred during the second trimester of gestation; a mechanical interference between essure and the developing pregnancy cannot be excluded and the reported death was, thus considered as related to the suspect insert. This case was considered an incident, due to fetal death. Based on the available information, there is no relationship between the reported events and a quality defect. No active follow-up will be pursued, as this case was identified during health authority website monitoring.

 
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Brand NameESSURE
Type of DeviceINSERT, TUBAL OCCLUSION
Manufacturer (Section D)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer Contact
k shaw lamberson
100 bayer blvd.
p.o. box 915
whippany , NJ 07981-0915
MDR Report Key5073517
Report Number2951250-2015-00922
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Type of Report Followup,Followup
Report Date 01/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberESS305
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2016
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
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/13/2015 Patient Sequence Number: 1
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