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

Model Number ESS305

Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Abdominal Pain (1685); Anemia (1706); Inflammation (1932); Pain (1994); Swelling (2091); Reaction (2414); Heavier Menses (2666); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

This spontaneous case was reported by a non-health professional and describes the occurrence of device dislocation ("two devices not found in the tests/ possible product migration from the fallopian tubes") and genital haemorrhage ("abundant bleeding that caused anemia") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), anaemia ("anemia"), abdominal pain ("abdominal pain"), arthralgia ("joint pain"), swelling ("swelling"), dermatitis allergic ("recurrent skin allergies") and allergy to metals ("allergic reactions to the product components").The patient was treated with surgery (will undergo a surgical procedure to remove essure).Essure treatment was not changed.At the time of the report, the device dislocation, genital haemorrhage, anaemia, abdominal pain, arthralgia, swelling and allergy to metals had not resolved and the dermatitis allergic outcome was unknown.The reporter provided no causality assessment for abdominal pain, anaemia, arthralgia, dermatitis allergic, device dislocation, genital haemorrhage and swelling with essure.The reporter considered allergy to metals to be related to essure.The reporter commented: report published on ¿apuntmedia.Es¿.The patient presented abdominal pain, joint pain, swelling, recurrent allergies in the skin, and abundant bleeding that caused anemia.Essure has caused her allergic reactions to the product components, and other unspecified effects.She will undergo a surgical procedure to remove the product; but her situation was complex since two devices were not found in the performed tests; a product migration from the fallopian tubes is possible.She has the hope to be better once the product has been removed, she has the sensation about her body has lost the battle against this diagnostic results: tests: two devices not found the list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred term: device dislocation.The analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.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.

Manufacturer Narrative

This spontaneous case was reported by a non-health professional and describes the occurrence of device dislocation ("two devices not found in the tests/ possible product migration from the fallopian tubes"), genital haemorrhage ("abundant bleeding that caused anemia") and haemorrhagic anaemia ("abundant bleeding that caused anemia") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), haemorrhagic anaemia (seriousness criterion medically significant), abdominal pain ("abdominal pain"), arthralgia ("joint pain"), swelling ("swelling"), dermatitis allergic ("recurrent skin allergies") and allergy to metals ("allergic reactions to the product components").The patient was treated with surgery (will undergo a surgical procedure to remove essure).Essure treatment was not changed.At the time of the report, the device dislocation, genital haemorrhage, haemorrhagic anaemia, abdominal pain, arthralgia, swelling and allergy to metals had not resolved and the dermatitis allergic outcome was unknown.The reporter provided no causality assessment for abdominal pain, arthralgia, dermatitis allergic, device dislocation, genital haemorrhage, haemorrhagic anaemia and swelling with essure.The reporter considered allergy to metals to be related to essure.The reporter commented: report published on ¿apuntmedia.Es¿.The patient presented abdominal pain, joint pain, swelling, recurrent allergies in the skin, and abundant bleeding that caused anemia.Essure has caused her allergic reactions to the product components, and other unspecified effects.She will undergo a surgical procedure to remove the product; but her situation was complex since two devices were not found in the performed tests; a product migration from the fallopian tubes is possible.She has the hope to be better once the product has been removed, she has the sensation about her body has lost the battle against this.Diagnostic results: tests: two devices not found.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-aug-2018: quality-safety evaluation of ptc.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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7662490
• MDR Text Key: 113160132
• Report Number: 2951250-2018-02966
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention