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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 Biocompatibility ; Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2014
Event Type  Injury  
Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain") in a female patient who had essure inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. On (b)(6) 2014, the patient had essure inserted. On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menstrual disorder ("persistent menstruation issues") and hypersensitivity ("allergic reaction"). The patient was treated with surgery (underwent a total hysterectomy due to complications from the essure). At the time of the report, the pelvic pain, menstrual disorder and hypersensitivity outcome was unknown. The reporter considered hypersensitivity, menstrual disorder and pelvic pain to be related to essure. Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: confirming essure device was successfully occluded. Company causality comment. Incident. 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 07981-0915
MDR Report Key6991724
Report Number2951250-2017-05870
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2017
Device MODEL NumberESS305
Device LOT NumberC76447
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 Received08/15/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/02/2014
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: 10/31/2017 Patient Sequence Number: 1
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