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

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Genital Bleeding (4507)

Event Type  Injury  

Event Description

This female patient was identified during an active online listening program.The patient had essure (lot no.Unknown) inserted for female sterilisation.The case describes the occurrence of genital haemorrhage ("one haemorrhage").Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.Essure was removed in (b)(6) 2018.On an unknown date, the patient had essure inserted.On unknown dates she experienced genital haemorrhage (seriousness criterion intervention required), perineal disorder ("perineum problem"), metal poisoning ("heavy metal poisoning"), skin discolouration ("gray skin"), fatigue ("fatigue"), multi-organ disorder ("descent of organs"), hernia ("two hernias") and allergy to metals ("she was allergic to chromium and nickel").The patient was treated with surgery (hysteroctomy & bilateral salpingectomy).At the time of the report, the fatigue had resolved and the genital haemorrhage, perineal disorder, metal poisoning, skin discolouration, multi-organ disorder, hernia and allergy to metals had not resolved.The reporter considered allergy to metals, fatigue, genital haemorrhage, hernia, metal poisoning, multi-organ disorder, perineal disorder and skin discolouration to be related to essure administration.The reporter commented: but once the implants have been removed, not everything goes back to how it was before.Has regained the use of her sight, her fatigue has gone, but there are still symptoms.For there were complications: a descent of organs, a hemorrhage, two hernias.She underwent five surgeries to remedy this.Diagnostic results (normal ranges are provided in parenthesis if available): [heavy metal test] (date unknown): she discovered.That she was allergic to chromium and nickel.Further company follow-up with the reporter or the reporter is not possible.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 female patient was identified during an active online listening program.The patient had essure (lot no.Unknown) inserted for female sterilisation.The case describes the occurrence of genital haemorrhage ("one haemorrhage").Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On unknown dates she experienced genital haemorrhage (seriousness criterion intervention required), perineal disorder ("perineum problem"), metal poisoning ("heavy metal poisoning"), skin discolouration ("gray skin"), fatigue ("fatigue"), multi-organ disorder ("descent of organs"), hernia ("two hernias") and allergy to metals ("she was allergic to chromium and nickel").The patient was treated with surgery (hysteroctomy & bilateral salpingectomy).At the time of the report, the fatigue had resolved and the genital haemorrhage, perineal disorder, metal poisoning, skin discolouration, multi-organ disorder, hernia and allergy to metals had not resolved.The reporter considered allergy to metals, fatigue, genital haemorrhage, hernia, metal poisoning, multi-organ disorder, perineal disorder and skin discolouration to be related to essure administration.The reporter commented: but once the implants have been removed, not everything goes back to how it was before.Has regained the use of her sight, her fatigue has gone, but there are still symptoms.For there were complications: a descent of organs, a hemorrhage, two hernias.She underwent five surgeries to remedy this.Diagnostic results (normal ranges are provided in parenthesis if available): [heavy metal test] (date unknown): she discovered that she was allergic to chromium and nickel.The following amendment was made: upon internal review it was found that argus cases (b)(4) are found duplicates of each other.Therefore (b)(4) needs to mark foe deletion & case (b)(4) needs to retained.All source documents, references, events, reporters & other relevant history are transferred from deletion case to retention case.No new follow-up information was received from the reporter.Further company follow-up with the reporter or the reporter is not possible.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: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 18976888
• MDR Text Key: 338549782
• Report Number: 2951250-2024-00211
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: Other,Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2024
• 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