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); Hair Loss (1877); Headache (1880); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Visual Disturbances (2140); Cramp(s) (2193); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('menorrhagia (heavy menstrual bleeding),') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In 2012, the patient had essure inserted.On an unknown date, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),"), dyspareunia ("dyspareunia (painful sexual intercourse),"), pelvic pain ("pelvic pain female"), abdominal pain ("abdominal pain"), back pain ("back pain"), menorrhagia (seriousness criterion medically significant), iron deficiency anaemia ("anemia"), vaginal discharge ("vaginal discharge"), alopecia ("hair loss"), tooth disorder ("dental problems"), headache ("headaches"), nausea ("nausea") and visual impairment ("vision problems") and was found to have weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the dysmenorrhoea, dyspareunia, pelvic pain, abdominal pain, back pain, menorrhagia, iron deficiency anaemia, vaginal discharge, alopecia, tooth disorder, headache, nausea, visual impairment and weight increased outcome was unknown.The reporter considered abdominal pain, alopecia, back pain, dysmenorrhoea, dyspareunia, headache, iron deficiency anaemia, menorrhagia, nausea, pelvic pain, tooth disorder, vaginal discharge, visual impairment and weight increased to be related to essure.The reporter commented: date of implant: (b)(6) 2013 - discrepancy noted.Plaintiff received treatment for dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), pelvic/ abdominal, back pain diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2013: result unknown.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 31-dec-2019: upon receiving a internal confirmation, it was confirmed that cases (b)(4) and (b)(4) duplicates of each other.All the information from the deletion case (b)(4) was transferred to retention case (b)(4).Nullification reason: duplicate case is identified with follow-up information.This case is marked for deletion.

• 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 07981
• MDR Report Key: 9580140
• MDR Text Key: 186455601
• Report Number: 2951250-2020-00409
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2020

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 Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Other