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

Model Number ESS305

Device Problems Malposition of Device (2616); Material Deformation (2976); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Pain (1994); Rash (2033); Urinary Frequency (2275); Heavier Menses (2666)

Event Date 07/01/2011

Event Type  Injury  

Event Description

A consumer had essure inserted 10 months after her last delivery.Four months later she had a hysterosalpingogram test performed.Before total occlusion confirmation she did not have intercourse.She started experiencing heavy vaginal bleeding, rash under arms, up at night to urinate 10 times and during the day up to 40 times and tiredness.In (b)(6) 2013, the pain got so bad she could not work or take care of her children.She had ultrasounds, magnetic resonance images and x-rays and was told that all looked fine.In (b)(6) 2012, her chiropractor did an x-ray of her back and noted that the coils were sideways and crooked on one side.On the other side the coil was bent out of shape.Another x-ray in (b)(6) 2013 showed the coils were worse than before.She went to the doctor because of these events and was told nothing was wrong.No treatment was given until she had a hysterectomy, salpingectomy and essure removed.She requested the removal.After the procedure she had pain from the incision, but no fever or redness on her abdomen.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

Manufacturer Narrative

This case was initially received via regulatory authority (food and drug administration, reference number: mw5032553) on 13-jan-2014.The most recent information was received on 05-feb-2014.Medical assessment the reported medical events are not necessarily indicative of a quality defect.No batch number was reported.No complaint sample was provided for technical investigation.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without a batch number or sample.At time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.Based on the available information, there is no reason to suspect a quality defect.This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('xray showed coils were sideways and crooked on one side'), pelvic pain ('pelvic pain') and pain ('tremendous amount of pain') in a 31-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "xray showed coil was bent out of shape on the other side.".The patient's medical history included delivery in september 2010.Concurrent conditions included nickel sensitivity and urticaria contact.In july 2011, the patient experienced pain (seriousness criterion medically significant), vaginal haemorrhage ("heavy vaginal bleeding"), rash ("rash under my arms"), nocturia ("up at night to urinate 10 times and during the day up to 40 times"), pollakiuria ("up at night to urinate 10 times and during the day up to 40 times") and fatigue ("tiredness").On 17-jul-2011, the patient had essure inserted.In january 2014, the patient experienced incision site pain ("incision pain").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("pinful menstrual cycle"), abdominal pain ("abdominal pain"), dyspareunia ("painful intercourse"), back pain ("back pain"), infection ("infection "), alopecia ("hair loss") and dysgeusia ("metal taste").The patient was treated with surgery (essure removal surgery), and.Essure was removed on (b)(6) 2014.On (b)(6) 2014, the vaginal haemorrhage, rash, nocturia, pollakiuria and fatigue had resolved.At the time of the report, the device dislocation and pain had resolved, the pelvic pain, dysmenorrhoea, abdominal pain, dyspareunia, back pain, infection, alopecia and dysgeusia outcome was unknown and the incision site pain was resolving.The reporter provided no causality assessment for device dislocation and incision site pain with essure.The reporter considered abdominal pain, alopecia, back pain, dysgeusia, dysmenorrhoea, dyspareunia, fatigue, infection, nocturia, pain, pelvic pain, pollakiuria, rash and vaginal haemorrhage to be related to essure.The reporter commented: discrepancy noted in date of insertion (b)(6) 2011, and date of removal (b)(6) 2014 (as given in deletion case) diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.6 kg/sqm.Quality-safety evaluation of ptc: final assessment.No lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.No capa investigation is required per criteria established in wi-03635, ¿processing essure cases in dev@com.¿ medical assessment the reported medical events are not necessarily indicative of a quality defect.No batch number was reported.No complaint sample was provided for technical investigation.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without a batch number or sample.At time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.Based on the available information, there is no reason to suspect a quality defect.Amendment: the report was amended for the following reason: case 2020-226575 found to be duplicate of this case and will be deleted.Information from duplicate case 2020-226575 (mfr number 2951250-2020-15021), events: pelvic pain, dysmenorrhea, abdominal pain, painful intercourse, back pain, infection nos, hair loss, metal taste, reporters information, patient aka name, product indication, rcc were added.No new follow-up information was received from the reporter.Based on the available information, a review of our complaint records and other relevant data was 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, CA 13353 ; GM 13353
• MDR Report Key: 3644257
• MDR Text Key: 15107222
• Report Number: 2951250-2014-00036
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 02/19/2014
• Supplement Dates Manufacturer Received: Not provided; 02/05/2014
• Supplement Dates FDA Received: 01/19/2017; 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 84