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); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pelvic pain / left side pain") in an adult female patient who had essure inserted (lot no.B60748,cs0003r) for female sterilization.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.Essure was removed on (b)(6) 2021.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), abdominal pain ("abdominal pain") and dysmenorrhoea ("dysmenorrhea (cramping)").The patient was treated with surgery (essure removal).At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal pain, dysmenorrhoea and pelvic pain to be related to essure administration.The reporter commented: she did not received treatment for pain.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] on 15-jul-2014: essure confirmation test(s) (unspecified) bilateral occlusion.[investigation] (date unknown): right tube exhibited no coils outised of the ostia.The left has 4.Batch no: b60748 production date: 2013-08-12 expiration date: 2016-08-31.Batch no: cs0003r production date: 2013-10-01 expiration date: 2016-05-31.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 02-may-2023: report from lawyer.Essure removal was reported.Case / event pelvic pain was upgraded to serious incident.Imdrf-fda synchronization.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant 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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pelvic pain / left side pain") in an adult female patient who had essure inserted (lot no.B60748,cs0003r) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.Essure was removed on (b)(6) 2021.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), abdominal pain ("abdominal pain") and dysmenorrhoea ("dysmenorrhea (cramping)").The patient was treated with surgery (essure removal).At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal pain, dysmenorrhoea and pelvic pain to be related to essure administration.The reporter commented: she did not received treatment for pain.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] on (b)(6) 2014: essure confirmation test(s) (unspecified) bilateral occlusion [investigation] (date unknown): right tube exhibited no coils outised of the ostia.The left has 4.Batch no: b60748, production date: 2013-08-12 & expiration date: 2016-08-31.Batch no: cs0003r, production date: 2013-10-01 & expiration date: 2016-05-31.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 20-jun-2023: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant 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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 17009763
• MDR Text Key: 316006268
• Report Number: 2951250-2023-02546
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: ESS305
• Device Lot Number: B60748,CS0003R
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2013
• 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