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 Abdominal Pain (1685); Anemia (1706); Fatigue (1849); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Urinary Tract Infection (2120); Heavier Menses (2666); Menorrhagia (4508); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/01/2014

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of genital haemorrhage ('bleeding: general abnormal bleeding/excessive bleeding'), menorrhagia ('bleeding- menorrhagia (heavy menstrual bleeding), abnormal bleeding (menorrhagia)') and blood loss anaemia ('bleeding-anemia') in an adult female patient who had essure (batch no.B59454) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced menorrhagia (seriousness criterion medically significant), pelvic pain ("pelvic pain/severe pain in pelvic area"), vaginal infection ("infection (bladder/urinary tract/vaginal type: vaginal") and vaginal haemorrhage ("abnormal bleeding (vaginal)").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), blood loss anaemia (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea (cramping)"), abdominal pain ("abdominal pain"), back pain ("back pain"), metrorrhagia ("metrorrhagia (bleeding b/w periods)") and fatigue ("fatigue").Essure treatment was not changed.At the time of the report, the genital haemorrhage, menorrhagia, blood loss anaemia, dysmenorrhoea, pelvic pain, abdominal pain, back pain, metrorrhagia, fatigue, vaginal infection and vaginal haemorrhage outcome was unknown.The reporter considered abdominal pain, back pain, blood loss anaemia, dysmenorrhoea, fatigue, genital haemorrhage, menorrhagia, metrorrhagia, pelvic pain, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: plaintiff received treatment for dysmenorrhea (cramping), pelvic pain, abdominal pain, menorrhagia, bleeding: general abnormal bleeding, metrorrhagia, anemia.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - in (b)(6) 2014: result: unknown.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 24-nov-2020: pfs and mr was received.Lot number was added.New event abnormal bleeding (vaginal) was added.Previously added infection updated with vaginal infection.Date of insertion updated.New reporters were added.Lab data was added.Event onset dates were added.Patient demographic was added.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 was reported by a lawyer and describes the occurrence of genital haemorrhage ('bleeding: general abnormal bleeding/excessive bleeding'), menorrhagia ('bleeding- menorrhagia (heavy menstrual bleeding), abnormal bleeding (menorrhagia)') and blood loss anaemia ('bleeding-anemia') in an adult female patient who had essure (batch no.B59454) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced menorrhagia (seriousness criterion medically significant), pelvic pain ("pelvic pain/severe pain in pelvic area"), vaginal infection ("infection (bladder/urinary tract/vaginal type: vaginal") and vaginal haemorrhage ("abnormal bleeding (vaginal)").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), blood loss anaemia (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea (cramping)"), abdominal pain ("abdominal pain"), back pain ("back pain"), metrorrhagia ("metrorrhagia (bleeding b/w periods)") and fatigue ("fatigue").Essure treatment was not changed.At the time of the report, the genital haemorrhage, menorrhagia, blood loss anaemia, dysmenorrhoea, pelvic pain, abdominal pain, back pain, metrorrhagia, fatigue, vaginal infection and vaginal haemorrhage outcome was unknown.The reporter considered abdominal pain, back pain, blood loss anaemia, dysmenorrhoea, fatigue, genital haemorrhage, menorrhagia, metrorrhagia, pelvic pain, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: plaintiff received treatment for dysmenorrhea (cramping), pelvic pain, abdominal pain, menorrhagia, bleeding: general abnormal bleeding, metrorrhagia, anemia.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - in (b)(6) 2014: result : unknown.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-dec-2020: quality safety evaluation of product technical complaint.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this 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: 10923907
• MDR Text Key: 218916498
• Report Number: 2951250-2020-15742
• 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
• Report Date: 12/02/2020

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 Expiration Date: 07/31/2016
• Device Model Number: ESS305
• Device Lot Number: B59454
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR