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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Pain (1994); Cramp(s) (2193); Depression (2361); Skin Inflammation (2443)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("strong pelvic pains, can't function feeling that intense pain daily/persistent pelvic pain") in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multiparous, liposuction, multigravida and parity 2 ((b)(6) 2014; (b)(6) 1997).She did not claimed that she is allergic and experience a hypersensitivity reaction to nickel or any other component of essure.Concomitant products included ibuprofen for pelvic pain, migraine and back pain as well as hydrochlorothiazide since (b)(6) 2016, ibuprofen (motrin), iron since 2016, paracetamol (tylenol) and trazodone since (b)(6) 2017.In (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced migraine ("migraines").In (b)(6) 2014, the patient experienced tooth disorder ("dental issues").In (b)(6) 2015, the patient experienced vaginal haemorrhage ("abnormal vaginal bleeding"), dermatitis ("dermatitis"), hypokalaemia ("potassium deficiency"), anaemia ("anemia"), fatigue ("fatigue"), alopecia ("hair loss") and female sexual dysfunction ("inability to engage in intercourse").In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain lower ("cramping").In 2016, the patient experienced depression ("depression").In (b)(6) 2016, the patient experienced abdominal pain ("abdominal pain").In (b)(6) 2016, the patient experienced weight increased ("weight gain").On an unknown date, the patient experienced pain in extremity ("leg pains"), amnesia ("significant memory loss"), headache ("increase in headaches"), loss of libido ("inability to engage in intercourse"), iron deficiency ("iron deficiency/ iron deficit"), dyspareunia ("vaginal pain with intercourse") and anxiety ("anxiety").The patient was treated with surgery ((b)(6) 2018.Hysterectomy.).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, vaginal haemorrhage, migraine and dyspareunia had resolved, the pain in extremity, amnesia, headache, depression, abdominal pain, anxiety and female sexual dysfunction had not resolved and the loss of libido, dermatitis, iron deficiency, hypokalaemia, anaemia, tooth disorder, abdominal pain lower, fatigue, alopecia and weight increased outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, alopecia, amnesia, anaemia, anxiety, depression, dermatitis, dyspareunia, fatigue, female sexual dysfunction, headache, hypokalaemia, iron deficiency, loss of libido, migraine, pain in extremity, pelvic pain, tooth disorder, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2014: essure confirmation test.Quality-safety evaluation of ptc: final assessment: for cases where a device failure during insertion is reported.We conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode fir the device.Medical assessment: based on the available information, there is no relationship between the reported event(s) and a quality defect.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 21-may-2018: plaintiff fact sheet received.Events per pfs: inability to engage in intercourse.On (b)(6) 2018, essure removal surgery done.Outcome updated.Patient's date of birth updated.Incident: at the time of reporting, 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
• 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: 7581939
• MDR Text Key: 110471308
• Report Number: 2951250-2018-02554
• Device Sequence Number: 1
• Product Code: HHS
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• 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: 05/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: HYDROCHLOROTHIAZIDE; IBUPROFEN; IRON; MOTRIN; TRAZODONE; TYLENOL [PARACETAMOL]
• Patient Outcome(s): Other; Required Intervention