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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Pain (1994); Rash (2033); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("essure fragments") 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 device breakage (seriousness criterion medically significant), rash ("rash/ liver rash") and pain ("sores").At the time of the report, the device breakage, rash and pain outcome was unknown.The reporter considered device breakage, pain and rash to be related to essure.Concerning the injuries reported in this case, the following ones were reported via social media: device breakage, rash, pain.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

Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("essure fragments") 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 device breakage (seriousness criterion medically significant), rash ("rash/sores"), pain ("sores") and liver disorder ("liver rash").At the time of the report, the device breakage, rash, pain and liver disorder outcome was unknown.The reporter considered device breakage, liver disorder, pain and rash to be related to essure.The reporter commented: the consumer described that she got to have a liver panel testing.Concerning the injuries reported in this case, the following one/ones were reported via social media: device breakage, rash, pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-oct-2018: quality safety evaluation of product technical complaint.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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("essure fragments") 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 device breakage (seriousness criterion medically significant), rash ("rash/sores"), pain ("sores") and liver disorder ("liver rash").At the time of the report, the device breakage, rash, pain and liver disorder outcome was unknown.The reporter considered device breakage, liver disorder, pain and rash to be related to essure.The reporter commented: the consumer described that she got to have a liver panel testing.Concerning the injuries reported in this case, the following one/ones were reported via social media: device breakage, rash, pain.Most recent follow-up information incorporated above includes: on 28-jun-2018: correction following company internal coding review.The event rash/ liver rash was changed to rash/sores and an event liver rash was created.In addition an reporter comment was added.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; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7643219
• MDR Text Key: 112861713
• Report Number: 2951250-2018-02867
• Device Sequence Number: 1
• Product Code: HHS
• 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,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other