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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 ESS205
Device Problem No Information
Event Type  Injury  
Manufacturer Narrative

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

 
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 september 2015. This is a spontaneous case report received from a regulatory authority ((b)(4)) in united states on 06-aug-2015 which refers to a fetus whose mother of unspecified age had essure (fallopian tube occlusion insert) inserted in 2006. The mother had severe complications which led to a complete hysterectomy at almost (b)(6)weeks pregnant. The fetus died (mother's 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. At (b)(6) weeks of consumer's pregnancy, she was submitted to a hysterectomy due to severe complications (unspecified) and the fetus died. The reported event was considered serious due to fatal outcome and is unlisted according to essure's reference safety information. In this particular case, limited information was provided. The complications experienced by the mother were not specified and no information was provided about fetal disorders. Nevertheless, considering the fetus died during the second trimester of gestation; a mechanical interference between essure and the developing pregnancy cannot be excluded. Therefore, the reported event was considered as possibly related to the suspect insert. 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

Product technical complaint investigation and final assessment were received on (b)(6)2015: (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: this ptc was initiated due to a lack of efficacy. A contraceptive failure may occur with the use of any contraceptive and is not indicative of a quality deficit per se. The reported adverse events are not indicative of a quality deficit per se. No batch number was reported. Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible. Neither batch number nor complaint sample was available for a technical investigation. The technical assessment concluded unconfirmed quality defect. In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report. 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. At 20 weeks of consumer's pregnancy, she was submitted to a hysterectomy due to severe complications (unspecified) and the fetus died. The reported event was considered serious due to fatal outcome and is unlisted according to essure's reference safety information. In this particular case, limited information was provided. The complications experienced by the mother were not specified and no information was provided about fetal disorders. Nevertheless, considering the fetus died during the second trimester of gestation; a mechanical interference between essure and the developing pregnancy cannot be excluded. Therefore, the reported event was considered as possibly related to the suspect insert. In this case neither batch number nor complaint sample were available for a technical investigation. The technical assessment concluded "unconfirmed quality defect". In summary, there is no reason to suspect a causal relationship to a potential quality deficit. No active follow-up will be pursued, as this case was identified during health authority website monitoring.

 
Manufacturer Narrative

Internal correction on 24-nov-2015. During internal review it was notified that the previously reported initial receipt date 06-aug-2015 is incorrect. The correct initial receipt date of the case is 09-aug-2015.

 
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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 Key5041671
Report Number2951250-2015-00668
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 01/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberESS205
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2015
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: 08/31/2015 Patient Sequence Number: 1
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