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 Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Arthralgia (2355); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (food and drug administration, reference number: mw5083162) on 06-feb-2019.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Concomitant products included bupropion hydrochloride (wellbutrin), cefixime (flexeril), cetirizine hydrochloride, ibuprofen, omeprazole (protonix), topiramate (topamax), trazodone and vitamins nos (multivitamins).On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria disability, medically significant and intervention required), menorrhagia ("ridiculously heavy periods"), mood swings ("mood swings"), fatigue ("constant fatigue"), arthralgia ("terrible joint pain"), rash ("skin rashes"), dry skin ("dry patches of skin"), amnesia ("memory loss"), tooth disorder ("dental problems"), migraine ("migraines") and alopecia ("hair loss") and was found to have weight increased ("unexplained weight gain").The patient was treated with surgery (hysterectomy scheduled in 2019).At the time of the report, the pelvic pain, menorrhagia, mood swings, fatigue, arthralgia, rash, dry skin, amnesia, tooth disorder, weight increased, migraine and alopecia outcome was unknown.The reporter considered alopecia, amnesia, arthralgia, dry skin, fatigue, menorrhagia, migraine, mood swings, pelvic pain, rash, tooth disorder and weight increased to be related to essure.The reporter commented: an injury (disability/permanent damage and serious events) was mentioned but not specified and /or assigned to one of the events.Incident no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This case was initially received via regulatory authority (food and drug administration, reference number: mw5083162) on (b)(6) 2019.The most recent information was received on 23-may-2019.Quality-safety evaluation of ptc: unable to confirm complaint this spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ('pelvic pain') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Concomitant products included bupropion hydrochloride (wellbutrin), cefixime (flexeril), cetirizine hydrochloride, ibuprofen, omeprazole (protonix), topiramate (topamax), trazodone and vitamins nos (multivitamins).On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria disability, medically significant and intervention required), menorrhagia ("radiculously heavy periods"), mood swings ("mood swings"), fatigue ("constant fatigue"), arthralgia ("terrible joint pain"), rash ("skin rashes"), dry skin ("dry patches of skin"), amnesia ("memory loss"), tooth disorder ("dental problems"), migraine ("migraines") and alopecia ("hair loss") and was found to have weight increased ("unexplained weight gain").The patient was treated with surgery (hysterectomy scheduled in 2019).At the time of the report, the pelvic pain, menorrhagia, mood swings, fatigue, arthralgia, rash, dry skin, amnesia, tooth disorder, weight increased, migraine and alopecia outcome was unknown.The reporter considered alopecia, amnesia, arthralgia, dry skin, fatigue, menorrhagia, migraine, mood swings, pelvic pain, rash, tooth disorder and weight increased to be related to essure.The reporter commented: an injury (disability/permanent damage and serious events) was mentioned but not specified and /or assigned to one of the events.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 ptc.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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: 8319542
• MDR Text Key: 135498910
• Report Number: 2951250-2019-00650
• 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: 05/23/2019

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: 02/06/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CETIRIZINE HYDROCHLORIDE.; CETIRIZINE HYDROCHLORIDE.; FLEXERIL [CEFIXIME].; FLEXERIL [CEFIXIME].; IBUPROFEN.; IBUPROFEN.; MULTIVITAMINS [VITAMINS NOS].; MULTIVITAMINS [VITAMINS NOS].; PROTONIX [OMEPRAZOLE].; PROTONIX [OMEPRAZOLE].; TOPAMAX.; TOPAMAX.; TRAZODONE.; TRAZODONE.; WELLBUTRIN.; WELLBUTRIN.; CETIRIZINE HYDROCHLORIDE; FLEXERIL [CEFIXIME]; IBUPROFEN; MULTIVITAMINS [VITAMINS NOS]; PROTONIX [OMEPRAZOLE]; TOPAMAX; TRAZODONE; WELLBUTRIN
• Patient Outcome(s): Other; Required Intervention; Disability