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 Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

This spontaneous case describes the occurrence of allergy to metals ('allergic reaction to nickel') 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 "risk of corrosion".On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criterion intervention required), adverse drug reaction ("serious side effects"), migraine ("chronic migraines") and mobility decreased ("loss of mobility of some parts of their bodies").The patient was treated with surgery (removal of tubes and uterus).The reporter considered adverse drug reaction, allergy to metals, migraine and mobility decreased 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 allergy to metals ("allergic reaction to nickel") and walking disability ("disabled situation (wheelchair)") in a female patient who had essure inserted.Additional non-serious events are detailed below.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 allergy to metals (seriousness criterion intervention required), walking disability (seriousness criterion disability), adverse reaction ("serious side effects / side effects"), migraine ("chronic migraines"), mobility decreased ("loss of mobility of some parts of their bodies / loss of mobility"), genital haemorrhage ("bleeding"), fatigue ("fatigue"), headache ("headaches"), myalgia ("muscle pain") and nervous system disorder ("neurological disorders").The patient was treated with surgery (removal of tubes and uterus).Essure was removed.The reporter considered adverse reaction, allergy to metals, fatigue, genital haemorrhage, headache, migraine, mobility decreased, myalgia, nervous system disorder and walking disability 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 product technical complaint.On 28-oct-2022: ha reference number added.On 28-oct-2022: ha reference number added.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.

Manufacturer Narrative

This spontaneous case describes the occurrence of allergy to metals ("allergic reaction to nickel") and walking disability ("disabled situation (wheelchair)") in a female patient who had essure inserted.Additional non-serious events are detailed below.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 allergy to metals (seriousness criterion intervention required), walking disability (seriousness criterion disability), adverse reaction ("serious side effects / side effects"), migraine ("chronic migraines"), mobility decreased ("loss of mobility of some parts of their bodies / loss of mobility"), genital haemorrhage ("bleeding"), fatigue ("fatigue"), headache ("headaches"), myalgia ("muscle pain") and nervous system disorder ("neurological disorders").The patient was treated with surgery (removal of tubes and uterus).Essure was removed.The reporter considered adverse reaction, allergy to metals, fatigue, genital haemorrhage, headache, migraine, mobility decreased, myalgia, nervous system disorder and walking disability to be related to essure administration.The most recent follow-up information incorporated above includes data received on: 27-oct-2022: upon receiving a internal review, it was confirmed that cases (b)(4) are duplicates of each other.All the information from deleted duplicate case (b)(4) transferred to the retention case (b)(4).E2b company number added, reporter information added, removed event - risk of corrosion.Events added - bleeding, side effects, fatigue, headaches, muscle pain, neurological disorders, disabled situation.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.

• 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: 15681764
• MDR Text Key: 302504943
• Report Number: 2951250-2022-01227
• 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,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; Disability
• Patient Sex: Female