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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Depression (2361); Unspecified Nervous System Problem (4426); Genital Bleeding (4507); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of genital haemorrhage ('heavy bleeding') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), tooth loss ("teeth loss"), nervous system disorder ("neurological issues"), decreased appetite ("loss of appetite"), anaemia ("anemia") and depression ("depression") and was found to have weight decreased ("weight loss") and weight increased ("weight gain").The patient was treated with surgery (surgery to remove inplant device).Essure was removed on (b)(6) 2020.At the time of the report, the genital haemorrhage, tooth loss, nervous system disorder, weight decreased, decreased appetite, anaemia, depression and weight increased outcome was unknown.The reporter considered anaemia, decreased appetite, depression, genital haemorrhage, nervous system disorder, tooth loss, weight decreased and weight increased to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.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 was reported by a lawyer and describes the occurrence of genital haemorrhage ('heavy bleeding') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), tooth loss ("teeth loss"), nervous system disorder ("neurological issues"), decreased appetite ("loss of appetite"), anaemia ("anemia") and depression ("depression") and was found to have weight decreased ("weight loss") and weight increased ("weight gain").The patient was treated with surgery (surgery to remove inplant device).Essure was removed on (b)(6) 2020.At the time of the report, the genital haemorrhage, tooth loss, nervous system disorder, weight decreased, decreased appetite, anaemia, depression and weight increased outcome was unknown.The reporter considered anaemia, decreased appetite, depression, genital haemorrhage, nervous system disorder, tooth loss, weight decreased and weight increased to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-oct-2020: 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of genital haemorrhage ('heavy bleeding') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included essential hypertension, back pain, dysmenorrhea, obesity, smoker, vaginal discharge, vaginal odor, headache and cesarean delivery, without mention of indication (-(b)(6) 2006,(b)(6) 2010,(b)(6) r2013).Previously administered products included for an unreported indication: hydrocodone and penicillin reaction.Concomitant products included docusate, ferrous sulfate, hydrochlorothiazide, ibuprofen, ketorolac tromethamine (toradol), nsaids, paracetamol (acetaminophen) and prochlorperazine.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), tooth loss ("teeth loss"), nervous system disorder ("neurological issues"), decreased appetite ("loss of appetite"), anaemia ("anemia") and depression ("depression") and was found to have weight decreased ("weight loss") and weight increased ("weight gain").The patient was treated with surgery (laparoscopic bilateral salpingectomy laparoscopic removal of essure.).Essure was removed on (b)(6) 2020.At the time of the report, the genital haemorrhage, tooth loss, nervous system disorder, weight decreased, decreased appetite, anaemia, depression and weight increased outcome was unknown.The reporter considered anaemia, decreased appetite, depression, genital haemorrhage, nervous system disorder, tooth loss, weight decreased and weight increased to be related to essure.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 8-jun-2021: medical records reporter information, medical history and concomitant medication were 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.

• 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: 10721660
• MDR Text Key: 212775419
• Report Number: 2951250-2020-15185
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 10/27/2020; 06/08/2021
• Supplement Dates FDA Received: 10/27/2020; 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; DOCUSATE; FERROUS SULFATE; HYDROCHLOROTHIAZIDE; IBUPROFEN; NSAIDS; PROCHLORPERAZINE; TORADOL
• Patient Outcome(s): Other; Required Intervention