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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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BAYER PHARMA AG ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Model Number ESS305
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Ectopic Pregnancy (1819); Pain (1994); Abdominal Distention (2601); Weight Changes (2607)
Event Type  Injury  
Event Description
This retrospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") and ectopic pregnancy with contraceptive device ("ectopic pregnancy") in a female patient who had essure inserted. The occurrence of additional non-serious events is detailed below. Other product or product use issues identified: device ineffective "device ineffective". In (b)(6) 2010, the patient had essure inserted. On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), abdominal distension ("bloating") and weight increased ("weight gain"). Last menstrual period and estimated date of delivery were not provided. The patient had essure in place during the first trimester of pregnancy. The patient was treated with surgery (to remove the essure implant). Essure was removed on (b)(6) 2017. At the time of the report, the pelvic pain, ectopic pregnancy with contraceptive device, abdominal distension and weight increased outcome was unknown. The reporter considered abdominal distension, ectopic pregnancy with contraceptive device, pelvic pain and weight increased to be related to essure. The reporter commented: need for additional surgery. No lot number or sample available for investigation. There is no evidence that a device related defect or malfunction caused a death or serious injury. If additional information becomes available it will be provided on a supplemental report.
 
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Brand NameESSURE
Type of DeviceTRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
BAYER PHARMA AG
müllerstr. 178
berlin, 13353
GM 13353
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, 13353
GM 13353
Manufacturer Contact
k shaw lamberson
100 bayer blvd, p.o. box 915
whippany, NJ 07981
MDR Report Key7295464
MDR Text Key100892448
Report Number2951250-2018-00849
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P020014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/01/2013
Device Model NumberESS305
Device Lot Number754207
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2010
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: 02/26/2018 Patient Sequence Number: 1
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