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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Rash (2033); Urticaria (2278); Anxiety (2328); Depression (2361); Confusion/ Disorientation (2553)

Event Date 08/03/2010

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain pelvic region, particularly the right side') in a (b)(6) female patient who had essure (batch no.664592) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for hypothyroidism: synthroid from 1985 to (b)(6) 2019; for anxiety: prozac in 1990; for an unreported indication: ortho tricyclene lo.Past adverse reactions to the above products included depression with prozac; and raynaud's phenomenon with synthroid.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced rash ("rashes or skin conditions: rashes") and urticaria ("rashes or skin conditions: hives").In (b)(6) 2010, the patient experienced teeth brittle ("dental problems: brittle teeth"), tooth fracture ("dental problems: teeth breakage") and gingival pain ("dental problems: gum sensitivity").In 2012, the patient experienced alopecia ("hair loss").In 2013, the patient experienced mood swings ("hormonal changes: mood swings") and feeling abnormal ("hormonal changes: brain fog").In (b)(6) 2013, the patient experienced allergy to metals ("nickel allergy").On (b)(6) 2013, the patient experienced depression ("psychological or psychiatric problems: depression") and anxiety ("psychological or psychiatric problems: anxiety").In (b)(6) 2014, the patient experienced migraine ("migraines") and headache ("headaches").In (b)(6) 2018, the patient experienced vulvovaginal mycotic infection ("infection (other): yeast").The patient was treated with pulled teeth and surgery (hysterectomy(full) with bilateral salpingectomy on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, rash, urticaria and migraine had resolved and the mood swings, feeling abnormal, vulvovaginal mycotic infection, depression, anxiety, headache, teeth brittle, tooth fracture, gingival pain, allergy to metals and alopecia outcome was unknown.The reporter considered allergy to metals, alopecia, anxiety, depression, feeling abnormal, gingival pain, headache, migraine, mood swings, pelvic pain, rash, teeth brittle, tooth fracture, urticaria and vulvovaginal mycotic infection to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - on (b)(6) 2010: total bilateral occlusion.Device is in place.Most recent follow-up information incorporated above includes: on (b)(6) 2019: upon receiving follow-up confirmation via email, it was found that this case is a duplicate of case (b)(4) and hence all the information from this case has been transferred to case (b)(4).This case should hence be deleted from bayer database.Pfs received: reporter information, patient demographics added, product indication updated, new event injury replaced by new events hormonal changes: mood swings and brain fog, infection (other): yeast, psychological or psychiatric problems: depression and anxiety, rashes or skin conditions: rashes and hives, migraines, headaches, dental problems: brittle teeth, teeth breakage and gum sensitivity, nickel allergy, pain pelvic region and hair loss.Outcome for the events pelvic pain, rashes or skin conditions: rashes and hives and migraines added as recovered / resolved.

• 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: 8779800
• MDR Text Key: 150698494
• Report Number: 2951250-2019-03685
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: 664592
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 47 YR