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

Model Number ESS305

Device Problems Break (1069); Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of device breakage ("a lot of operations are failures due to broken inserts because of the lack of a protocol for removal") and complication of device removal ("a lot of operations are failures due to broken inserts because of the lack of a protocol for removal") in unknown number of female patients who had essure inserted.Other product or product use issues identified: circumstance or information capable of leading to device use error "a lot of operations are failures due to broken inserts because of the lack of a protocol for removal".On an unknown date, the patients had essure inserted.On an unknown date, the patients experienced device breakage and complication of device removal.At the time of the report, the device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal and device breakage to be related to essure.The reporter commented an article on a blog.The list of device similar events contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 12-jul-2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1652 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Further company follow-up with the consumer is not possible.Other reportable 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
• 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 07981-0915
• MDR Report Key: 6728831
• MDR Text Key: 80821001
• Report Number: 2951250-2017-02574
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2017
• 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