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

Model Number ESS305

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hair Loss (1877); Unspecified Infection (1930); Itching Sensation (1943); Memory Loss/Impairment (1958); Muscle Weakness (1967); Pain (1994); Myalgia (2238); Arthralgia (2355); Abdominal Distention (2601)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ((b)(6), reference number: (b)(4)) on 22-oct-2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") and genital haemorrhage ("bleedings") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), alopecia ("every day significant loss of hair"), pruritus ("itching"), skin discolouration ("spots on head skin"), myalgia ("muscular pain and weakness on lower limbs"), muscular weakness ("muscular pain and weakness on lower limbs"), back pain ("back and lumbar pain"), arthralgia ("joint pain"), cystitis ("cystitis"), vulvovaginal mycotic infection ("frequent vaginal mycosis"), fatigue ("fatigue"), abdominal distension ("swollen belly"), dyspnoea ("breathlessness"), disturbance in attention ("concentration disorders"), memory impairment ("memory disorders"), gastrointestinal disorder ("intestinal disorders"), pain ("diffused pain that change of location") and abdominal pain ("regular abdominal pain when she walked (with vibrations in belly)").At the time of the report, the pelvic pain, genital haemorrhage, alopecia, pruritus, skin discolouration, myalgia, muscular weakness, back pain, arthralgia, cystitis, vulvovaginal mycotic infection, fatigue, abdominal distension, dyspnoea, disturbance in attention, memory impairment, gastrointestinal disorder, pain and abdominal pain outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, alopecia, arthralgia, back pain, cystitis, disturbance in attention, dyspnoea, fatigue, gastrointestinal disorder, genital haemorrhage, memory impairment, muscular weakness, myalgia, pain, pelvic pain, pruritus, skin discolouration and vulvovaginal mycotic infection with essure.The reporter commented: the events happened a few months after insertion of essure.Further company follow-up with the regulatory authority is not possible.Incident: no lot number or sample available for investigation.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.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 22-oct-2018.The most recent information was received on 29-oct-2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") and genital haemorrhage ("bleedings") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), alopecia ("every day significant loss of hair"), pruritus ("itching"), skin discolouration ("spots on head skin"), myalgia ("muscular pain and weakness on lower limbs"), muscular weakness ("muscular pain and weakness on lower limbs"), back pain ("back and lumbar pain"), arthralgia ("joint pain"), cystitis ("cystitis"), vulvovaginal mycotic infection ("frequent vaginal mycosis"), fatigue ("fatigue"), abdominal distension ("swollen belly"), dyspnoea ("breathlessness"), disturbance in attention ("concentration disorders"), memory impairment ("memory disorders"), gastrointestinal disorder ("intestinal disorders"), pain ("diffused pain that change of location") and abdominal pain ("regular abdominal pain when she walked (with vibrations in belly)").At the time of the report, the pelvic pain, genital haemorrhage, alopecia, pruritus, skin discolouration, myalgia, muscular weakness, back pain, arthralgia, cystitis, vulvovaginal mycotic infection, fatigue, abdominal distension, dyspnoea, disturbance in attention, memory impairment, gastrointestinal disorder, pain and abdominal pain outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, alopecia, arthralgia, back pain, cystitis, disturbance in attention, dyspnoea, fatigue, gastrointestinal disorder, genital haemorrhage, memory impairment, muscular weakness, myalgia, pain, pelvic pain, pruritus, skin discolouration and vulvovaginal mycotic infection with essure.The reporter commented: the events happened a few months after insertion of essure.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 29-oct-2018: quality safety evaluation of ptc.Incident: no lot number or sample available for investigation.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; mullerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7994821
• MDR Text Key: 124683938
• Report Number: 2951250-2018-04379
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

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: 10/22/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 10/29/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other