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 Date 08/01/2015

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pelvic pain") in an adult female patient who had essure inserted (lot no.C49142) 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) 2015, the patient had essure inserted.In (b)(6) 2015 she experienced pelvic pain (seriousness criterion intervention required), abdominal pain ("abdominal pain"), back pain ("back pain"), abdominal distension ("bloating"), headache ("headaches"), fungal infection ("yeast infections"), migraine ("migraines") and urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: urinary tract") and was found to have weight increased ("weight gain").An unknown time later she experienced genital haemorrhage ("general abnormal bleeding"), intermenstrual bleeding ("metrorrhagia (bleeding between periods)"), menstruation irregular ("irregular period") and vaginal infection ("vaginal infection").The patient was treated with surgery (hysterectomy - uterus).Essure was removed on (b)(6) 2022.At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal distension, abdominal pain, back pain, fungal infection, genital haemorrhage, headache, intermenstrual bleeding, menstruation irregular, migraine, pelvic pain, urinary tract infection, vaginal infection and weight increased to be related to essure administration.The reporter commented: discrepancy noted insertion date: 2014, (b)(6) 2015, (b)(6) 2015, (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 23.73 kg/sqm.[hysterosalpingogram] on (b)(6) 2015: essure confirmation test (unspecified) result unknown.Concerning the injuries reported in this case, the following were described in patient¿s medical records: pelvic pain, bloating.Batch no c49142; production date 2014-04-10; expiration date 2017-04-30.The most recent follow-up information incorporated above includes data received on: 02-may-2023: report from lawyer.Essure removal added.Event pelvic pain was upgraded to serious incident.A technical investigation will be 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 (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pelvic pain") in an adult female patient who had essure inserted (lot no.C49142) 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) 2015, the patient had essure inserted.In (b)(6) 2015, she experienced pelvic pain (seriousness criterion intervention required), abdominal pain ("abdominal pain"), back pain ("back pain"), abdominal distension ("bloating"), headache ("headaches"), fungal infection ("yeast infections"), migraine ("migraines") and urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: urinary tract") and was found to have weight increased ("weight gain").Essure was removed on (b)(6) 2022.An unknown time later she experienced genital haemorrhage ("general abnormal bleeding"), intermenstrual bleeding ("metrorrhagia (bleeding between periods)"), menstruation irregular ("irregular period") and vaginal infection ("vaginal infection").The patient was treated with surgery (hysterectomy - uterus).At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal distension, abdominal pain, back pain, fungal infection, genital haemorrhage, headache, intermenstrual bleeding, menstruation irregular, migraine, pelvic pain, urinary tract infection, vaginal infection and weight increased to be related to essure administration.The reporter commented: discrepancy noted insertion date: 2014, (b)(6) 2015, (b)(6) 2015, (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 23.73 kg/sqm.[hysterosalpingogram] on (b)(6) 2015: essure confirmation test (unspecified) result unknown.Concerning the injuries reported in this case, the following were described in patient¿s medical records : pelvic pain, bloating.Batch no: c49142.Production date: 2014-04-10.Expiration date: 2017-04-30.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: 01-jun-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.

• 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: 17001185
• MDR Text Key: 315909871
• Report Number: 2951250-2023-02465
• 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: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: ESS305
• Device Lot Number: C49142
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2014
• 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 Age: 31 YR
• Patient Sex: Female
• Patient Weight: 79 KG