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 Pain (1994)

Event Date 01/01/2006

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 ("chronic pelvic pain, pain") in an adult female patient who had essure (ess205) inserted (lot no.12274611) for female sterilisation.Additional non-serious events are detailed below.Previously administered products included: depo-provera.Concurrent conditions were listed as asthma, anxiety, lower abdominal pain and irregular periods.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005 she experienced heavy menstrual bleeding ("excessive and abnormal bleeding during menstruation/ abnormal bleeding(menorrhagia)"), vaginal haemorrhage ("abnormal bleeding(vaginal)") and fatigue ("fatigue").In (b)(6) 2005 she experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2006 she experienced pelvic pain (seriousness criterion medically important).In (b)(6) 2006 she experienced headache ("migraines / headaches"), migraine ("migraines / headaches") and nausea ("nausea").In (b)(6) 2008 she experienced vaginal discharge ("vaginal discharge").An unknown time later she experienced genital haemorrhage ("abnormal bleeding(general)") and back pain ("lower back pain").Essure (ess205) treatment was not changed.At the time of the report, the outcomes for these events were unknown.The reporter considered back pain, dyspareunia, fatigue, genital haemorrhage, headache, heavy menstrual bleeding, migraine, nausea, pelvic pain, vaginal discharge and vaginal haemorrhage to be related to essure (ess205) administration.The reporter commented: the physician has recommended that she have the device removed via hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] on (b)(6) 2005: results: total bilateral occlusion.Quality-safety evaluation of ptc: for essure (ess205): unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 18-aug-2023: quality safety evaluation of ptc.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 ("chronic pelvic pain, pain") in an adult female patient who had essure (ess205) inserted (lot no.12274611) for female sterilisation.Additional non-serious events are detailed below.Previously administered products included: depo-provera.Concurrent conditions were listed as asthma, anxiety, lower abdominal pain and irregular periods.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005 she experienced heavy menstrual bleeding ("excessive and abnormal bleeding during menstruation/ abnormal bleeding(menorrhagia)"), vaginal haemorrhage ("abnormal bleeding(vaginal)") and fatigue ("fatigue").In (b)(6) 2005 she experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2006 she experienced pelvic pain (seriousness criterion medically important).In (b)(6) 2006 she experienced headache ("migraines / headaches"), migraine ("migraines / headaches") and nausea ("nausea").In (b)(6) 2008 she experienced vaginal discharge ("vaginal discharge").An unknown time later she experienced genital haemorrhage ("abnormal bleeding(general)") and back pain ("lower back pain").Essure (ess205) treatment was not changed.At the time of the report, the outcomes for these events were unknown.The reporter considered back pain, dyspareunia, fatigue, genital haemorrhage, headache, heavy menstrual bleeding, migraine, nausea, pelvic pain, vaginal discharge and vaginal haemorrhage to be related to essure (ess205) administration.The reporter commented: the physician has recommended that she have the device removed via hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] on (b)(6) 2005: results: total bilateral occlusion.Lot number: 12274611.Manufacture date: 2005-01.Expiration date: 2006-12.Quality-safety evaluation of ptc: for essure (ess205): 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: 28-aug-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: 17591237
• MDR Text Key: 321598112
• Report Number: 2951250-2023-02829
• 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: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2006
• Device Model Number: ESS205
• Device Lot Number: 12274611
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2023
• Date Device Manufactured: 01/01/2005
• 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): Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Race: White