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); Emotional Changes (1831); Hair Loss (1877); Headache (1880); Pain (1994); Anxiety (2328); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('abnormal bleeding (menorrhagia)') in an adult female patient who had essure (batch no.A73747) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included gallbladder removal.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), vaginal haemorrhage ("abnormal bleeding (vaginal"), mood swings ("psychological or psychiatric problems - mood swings"), anxiety ("anxiety,"), migraine ("migraines"), headache ("headaches,"), abdominal pain ("abdominal pain"), tooth disorder ("dental problems"), dyspareunia ("dyspareunia (painful sexual intercourse)"), alopecia ("hair loss") and back pain ("back pain").The patient was treated with surgery (ablation).Essure treatment was not changed.At the time of the report, the menorrhagia, pelvic pain, vaginal haemorrhage, mood swings, anxiety, migraine, headache, abdominal pain, tooth disorder, dyspareunia, alopecia and back pain outcome was unknown.The reporter considered abdominal pain, alopecia, anxiety, back pain, dyspareunia, headache, menorrhagia, migraine, mood swings, pelvic pain, tooth disorder and vaginal haemorrhage to be related to essure.Most recent follow-up information incorporated above includes: on 1-jul-2019: new pfs received- new events added: ablation, abnormal bleeding (vaginal, menorrhagia), psychological or psychiatric problems condition: mood swings, anxiety, migraines / headaches, dental problems, dyspareunia,pain, hair loss, abdominal pain, back pain were added.Lot number, lab data and new reporters were added.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('abnormal bleeding (menorrhagia)') in an adult female patient who had essure (batch no.A73747) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included gallbladder removal.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), vaginal haemorrhage ("abnormal bleeding (vaginal"), mood swings ("psychological or psychiatric problems - mood swings"), anxiety ("anxiety,"), migraine ("migraines"), headache ("headaches,"), abdominal pain ("abdominal pain"), tooth disorder ("dental problems"), dyspareunia ("dyspareunia (painful sexual intercourse)"), alopecia ("hair loss") and back pain ("back pain").The patient was treated with surgery (ablation).Essure treatment was not changed.At the time of the report, the menorrhagia, pelvic pain, vaginal haemorrhage, mood swings, anxiety, migraine, headache, abdominal pain, tooth disorder, dyspareunia, alopecia and back pain outcome was unknown.The reporter considered abdominal pain, alopecia, anxiety, back pain, dyspareunia, headache, menorrhagia, migraine, mood swings, pelvic pain, tooth disorder and vaginal haemorrhage to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: quality safety evaluation of product technical complaint.Incident we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformance's data; should any new and reportable information become available as a result, 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: 8770783
• MDR Text Key: 150396175
• Report Number: 2951250-2019-03507
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: ESS305
• Device Lot Number: A73747
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention