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

Model Number ESS205

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("the foreign-body material has been removed.") in a female patient who had essure (ess205) inserted (lot no.22012-invalid).There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2008, the patient had essure (ess205) inserted.An unknown time later she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery.At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure (ess205) administration.Lot number 22012 is invalid.Quality-safety evaluation of ptc: for essure (ess205): unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: (b)(6) 2022: device removal updated from ''no/unknown/not reported'' to ''yes'', injury not clarified to ''medical device removal'', list updated from ''unlisted'' to ''listed'', company causality changed from ''unrelated'' to ''related'', annex f updated from ''f11'' to ''f12, f15 and f1903'', action taken with drug added and annex e added.We received an invalid lot number in this case.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("the foreign-body material has been removed.") in a female patient who had essure (ess205) inserted (lot no.22012-invalid).There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2008, the patient had essure (ess205) inserted.An unknown time later she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery.At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure (ess205) administration.Lot number 22012 is invalid.Quality-safety evaluation of ptc: for essure (ess205): no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 07-dec-2022: quality safety evaluation of product technical complaint.06-dec-2022: ha reference number added.We received an invalid lot number in this case.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation 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
• 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
• MDR Report Key: 15897138
• MDR Text Key: 304682955
• Report Number: 2951250-2022-01488
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS205
• Device Lot Number: 22012-INVALID
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female