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

Model Number ESS305

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Genital Bleeding (4507)

Event Type  Injury  

Event Description

This spontaneous case describes the occurrence of genital haemorrhage ('bleeding') 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 material issue "corrosion".On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criterion intervention required), inflammation ("inflammatory reaction"), fatigue ("fatigue"), mobility decreased ("loss of mobility"), headache ("eadaches"), pelvic pain ("pain") and nervous system disorder ("neurological disorders").The patient was treated with surgery (removal of uterus and fallopian tube).The reporter considered fatigue, genital haemorrhage, headache, inflammation, mobility decreased, nervous system disorder and pelvic pain to be related to essure.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case describes the occurrence of genital haemorrhage ("bleeding") in a female patient who had essure inserted.Additional non-serious events are detailed below.Product or product use issues identified: device material corroded ("corrosion").There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On unknown dates she experienced genital haemorrhage (seriousness criterion intervention required), pelvic pain ("pain"), inflammation ("inflammatory reaction"), headache ("eadaches"), fatigue ("fatigue"), nervous system disorder ("neurological disorders") and mobility decreased ("loss of mobility").The patient was treated with surgery (removal of uterus and fallopian tube).Essure was removed.The reporter considered fatigue, genital haemorrhage, headache, inflammation, mobility decreased, nervous system disorder and pelvic pain to be related to essure administration.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 02-nov-2022: quality safety evaluation of ptc.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: 15681739
• MDR Text Key: 302502770
• Report Number: 2951250-2022-01228
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2022
• 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