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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pain") in a female patient who had essure inserted (lot no.C12707).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.On unknown date she experienced pelvic pain (seriousness criterion intervention required), dyspareunia ("dyspareunia") and genital haemorrhage ("irregular bleeding / heavy bleeding").The patient was treated with surgery (to remove essure).Essure was removed.At the time of the report, the outcomes for pelvic pain and dyspareunia were unknown.The reporter considered dyspareunia, genital haemorrhage and pelvic pain to be related to essure administration.The reporter commented: following the implantation of the device, the claimant reports experiencing symptoms including but not limited to pain, irregular bleeding, heavy bleeding, and dyspareunia.In addition, the claimant subsequently had to undergo surgery to remove the device due to the above symptoms.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: (b)(6) 2024: medical record received.Event injury nos is replaced with event pelvic pain female.New events dyspareunia & genital bleeding were added.Patient details address & dob added.Essure insertion date updated.We received a lot number.Based on this information, a technical investigation was conducted and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL 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: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 18709098
• MDR Text Key: 335406195
• Report Number: 2951250-2024-00107
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: ESS305
• Device Lot Number: C12707
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2024
• Date Device Manufactured: 01/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female