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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Pain (1994); Blurred Vision (2137); Hot Flashes/Flushes (2153); Cramp(s) (2193); Arthralgia (2355); Irritability (2421); Sensitivity of Teeth (2427); Confusion/ Disorientation (2553); Heavier Menses (2666)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (fda, reference number: mw5042084) on 26-jun-2015.The most recent information was received on 07-jun-2018.This spontaneous case was reported by a lawyer and describes the occurrence of back pain ("lower back pain") in a female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.In 2012, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criteria disability and intervention required), arthralgia ("hip pain/ joint pain"), groin pain ("shooting pain in the groin"), abdominal pain lower ("cramping"), menorrhagia ("heavy menstrual periods"), vaginal haemorrhage ("spotting"), fatigue ("severe fatigue"), confusional state ("mental cloudiness"), sensitivity of teeth ("teeth sensitivity"), headache ("headache"), decreased appetite ("decrease of appetite"), alopecia ("hair loss"), vision blurred ("blurred vision"), irritability ("irritability"), dysgeusia ("metallic taste in my mouth"), skin lesion ("skin lesions"), hot flush ("hot flashes") and hyperacusis ("sensitivity to noise").The patient was treated with surgery (finally scheduled for a hysterectomy on (b)(4) 2016 after 3 years).At the time of the report, the back pain, arthralgia, groin pain, abdominal pain lower, menorrhagia, vaginal haemorrhage, fatigue, confusional state, sensitivity of teeth, headache, decreased appetite, alopecia, vision blurred, irritability, dysgeusia, skin lesion, hot flush and hyperacusis outcome was unknown.The reporter considered abdominal pain lower, alopecia, arthralgia, back pain, confusional state, decreased appetite, dysgeusia, fatigue, groin pain, headache, hot flush, hyperacusis, irritability, menorrhagia, sensitivity of teeth, skin lesion, vaginal haemorrhage and vision blurred to be related to essure.Quality-safety evaluation of ptc: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.No new failure mode has been identified.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The reported adverse events considered related are known possible undesirable events and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.Neither batch number nor complaint sample were available for further technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Most recent follow-up information incorporated above includes: on 7-jun-2018: content from social media: finally scheduled for a hysterectomy on 22-nov-2016 after 3 years and event intervention required criteria ticked.Incident no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental 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 07981
• MDR Report Key: 7628990
• MDR Text Key: 112023172
• Report Number: 2951250-2018-02751
• Device Sequence Number: 1
• Product Code: HHS
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability