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

Model Number ESS205

Device Problem 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 ("severe long pelvic pain") in an adult female patient who had essure (ess205) inserted.Additional non-serious events are detailed below.Product or product use issues identified: device failure, defect ("failure defect (incl other organ damage)").There was no information on the patient's medical history or concurrent conditions.In (b)(6) 2004, the patient had essure (ess205) inserted.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), injury ("failure defect (incl other organ damage)"), sexual dysfunction ("severe long sexual dysfunction") and mental disorder ("unspecified psych injury").The patient was treated with surgery (hysterectomy (laparoscopic)).Essure (ess205) was removed.The reporter considered injury, mental disorder, pelvic pain and sexual dysfunction to be related to essure (ess205) administration.The reporter commented: intention to remove the essure device.On (b)(6) 2023 essure removal was reported.Also stated that essure had impact on lifestyle.Quality-safety evaluation of ptc: for essure (ess205): unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 01-feb-2023: the correct ird is (b)(6) 2023.As reported events pelvic pain and sexual disfunction updated, added unspecified psych injury.Essure removal surgery reported so case was upgraded to serious incident.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 16399011
• MDR Text Key: 309866444
• Report Number: 2951250-2023-00547
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS205
• Date Manufacturer Received: 02/01/2023
• 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