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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fatigue (1849); Hair Loss (1877); Pain (1994); Swelling (2091); Confusion/ Disorientation (2553); Abdominal Distention (2601); Weight Changes (2607); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('he is removing my tubes and coils next month.') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2011, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required), was found to have weight increased ("weight gain") and experienced abdominal distension ("belly bloating"), alopecia ("hair thinning"), fatigue ("extreme fatigue"), feeling abnormal ("brain fog"), peripheral swelling ("swelling fingers, feet"), joint swelling ("swelling ankles"), pain in extremity ("foot pain when i wake up") and gait disturbance ("so bad i can barely walk when i first got up").The patient was treated with surgery (essure removal surgery).Essure was removed.At the time of the report, the medical device removal, weight increased, abdominal distension, alopecia, fatigue, feeling abnormal, peripheral swelling, joint swelling, pain in extremity and gait disturbance outcome was unknown.The reporter considered abdominal distension, alopecia, fatigue, feeling abnormal, gait disturbance, joint swelling, medical device removal, pain in extremity, peripheral swelling and weight increased to be related to essure.Concerning the injuries reported in this case, the following one/ones were reported via social media: weight gain, belly bloating, hair thinning, extreme fatigue, brain fog, swelling fingers, feet, swelling ankles, foot pain when i wake up and so bad i can barely walk when i first got up.Most recent follow-up information incorporated above includes: on 19-jul-2019: social media case - new events weight gain, belly bloating, hair thinning, extreme fatigue, brain fog, swelling fingers, feet, swelling ankles, foot pain when i wake up and so bad i can barely walk when i first got up were added.Essure insertion date were added.No lot number 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 spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('he is removing my tubes and coils next month.') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In 2011, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required), was found to have weight increased ("weight gain") and experienced abdominal distension ("belly bloating"), alopecia ("hair thinning"), fatigue ("extreme fatigue"), feeling abnormal ("brain fog"), peripheral swelling ("swelling fingers, feet"), joint swelling ("swelling ankles"), pain in extremity ("foot pain when i wake up") and gait disturbance ("so bad i can barely walk when i first got up").The patient was treated with surgery (essure removal surgery).Essure was removed.At the time of the report, the medical device removal, weight increased, abdominal distension, alopecia, fatigue, feeling abnormal, peripheral swelling, joint swelling, pain in extremity and gait disturbance outcome was unknown.The reporter considered abdominal distension, alopecia, fatigue, feeling abnormal, gait disturbance, joint swelling, medical device removal, pain in extremity, peripheral swelling and weight increased to be related to essure.Concerning the injuries reported in this case, the following one/ones were reported via social media: weight gain, belly bloating, hair thinning, extreme fatigue, brain fog, swelling fingers, feet, swelling ankles, foot pain when i wake up and so bad i can barely walk when i first got up.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.(product technical complaint) and ppc added.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-conformance's 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: 8835433
• MDR Text Key: 152461083
• Report Number: 2951250-2019-04246
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• 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
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention