MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number ESS305

Device Problem Product Quality Problem (1506)

Patient Problems Abdominal Pain (1685); Neuropathy (1983); Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case report was received from a female consumer of unspecified age via regulatory authority (case# mw5032842) in united states on 13-jan-2014 referring to herself.The consumer had essure (fallopian tube occlusion insert) inserted and experienced pain on my right side all the time since it healed.No information given on consumer's history, past drugs, concomitant drugs and concurrent conditions.On an unspecified date the consumer had essure (fallopian tube occlusion insert) placed.Lot number was not informed.On an unspecified date the consumer experienced pain on her right side all the time since it healed.Consumer considered the event as medical important.It was not reported if essure was removed after events.Consumer's outcome was not informed.No assessment was given.Follow up information received from the consumer on 12-oct-2015: case upgraded to incident.She mentioned that she has had essure for 6 years and the last 4 have been the worst.She had 25 different things wrong with her due to the coils.She was on a lot of medicine and vitamin.On (b)(6) 2015 she would have to go to a specialist for neuropathy in her arms, legs, and shoulder.She was going to get them removed next month ((b)(6)2015) and was also going to ask her doctor for pictures and her coils after her full hysterectomy next month.Product technical complaint investigation result was received on 28-oct-2015: the ptc global reference number is (b)(4).Final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.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.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: no product quality defect was confirmed therefore a relationship to the reported medical events is excluded.The reported medical events are not indicative of a quality deficit per se.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical events and a quality defect.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had pain on her right side after essure (fallopian tube occlusion insert) insertion.She stated she will be submitted to a hysterectomy in the month following this report.This event is listed according to essure's reference safety information.After essure insertion abdominal, pelvic and uncharacterized pain may occur.In this case, limited information was provided.Nevertheless, considering event's nature; causality with the suspect insert cannot be excluded.In addition non-serious events were reported.This case was upgraded to incident, since according to information received upon follow-up, a surgical intervention will be required for device removal.Product technical analysis was performed with neither batch number nor complaint sample.According to results there is no relationship between the reported medical event(s) and quality defect.Further information from consumer is expected.

Manufacturer Narrative

Follow-up information received on 05-dec-2015 from consumer via social media: the consumer stated she had major complications due to essure, such as bowel infected and bladder repair.Follow-up information received on 07-dec-2015 from consumer via social media: the consumer mentioned uturas (as reported) attached to her bladder and bowel - she had it cut off her bowel.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had pain on her right side after essure (fallopian tube occlusion insert) insertion.She stated she would be submitted to a hysterectomy.This event is listed according to essure's reference safety information.After essure insertion abdominal, pelvic and uncharacterized pain may occur.In this case, limited information was provided.Nevertheless, considering event's nature; causality with the suspect insert cannot be excluded.Consumer also stated she had uturas (as reported) attached to her bladder and bowel; bowel infection and she had "it cut off" her bowel and underwent bladder repair.These events are unlisted in essure's reference safety information and due to the minimal information provided (it is unclear exactly which kind of infection consumer had and what she mean by "uturas"); their causality with the suspected insert was considered as not assessable.In addition non-serious events were reported.This case was upgraded to incident, since according to information received upon follow-up, a surgical intervention will be required for device removal.Product technical analysis was performed with neither batch number nor complaint sample.According to results there is no relationship between the reported medical events and quality defect.Further information from consumer is expected.

Manufacturer Narrative

Follow up information identified on 03-jan-2016 from social media: consumer reported that after her hysterectomy.She had nickel allergy 2 weeks after.She had it for 4 to 5 weeks.Follow-up from 26-jan-2016: follow-up attempts were performed with no response to date.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had pain on her right side after essure (fallopian tube occlusion insert) insertion.She had a hysterectomy.This event is listed according to essure's reference safety information.After essure insertion abdominal, pelvic and uncharacterized pain may occur.In this case, limited information was provided.Nevertheless, considering event's nature; causality with the suspect insert cannot be excluded.Consumer also stated she had uturas (as reported) attached to her bladder and bowel; bowel infection and she had "it cut off" her bowel and underwent bladder repair.These events are unlisted in essure's reference safety information and due to the minimal information provided (it is unclear exactly which kind of infection consumer had and what she mean by "uturas"); their causality with the suspected insert was considered as not assessable.In addition non-serious events were reported.This case was upgraded to incident since device removal was required (implied).Product technical analysis was performed with neither batch number nor complaint sample.According to results there is no relationship between the reported medical events and quality defect.Further information could not be obtained.

• Brand Name: ESSURE
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd.; milpitas CA 95035
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd., p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5204801
• MDR Text Key: 30535873
• Report Number: 2951250-2015-01379
• Device Sequence Number: 1
• Product Code: KNH
• 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,Followup,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2016
• 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): Other
• Patient Age: 32 YR