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 Abdominal Pain (1685); Emotional Changes (1831); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Rash (2033); Urticaria (2278); Anxiety (2328); Arthralgia (2355); Depression (2361); Sensitivity of Teeth (2427); Abdominal Distention (2601); Weight Changes (2607); Intermenstrual Bleeding (2665); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of genital haemorrhage ('general abnormal bleeding') in an adult 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 monitoring procedure not performed "she did not undergo an essure confirmation test".The patient's previously administered products included for an unreported indication: yaz and depo provera.Concurrent conditions included morbid obesity.Concomitant products included omeprazole.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)") and abdominal distension ("gastrointestinal or digestive system condition type: bloating").In (b)(6) 2009, the patient experienced migraine ("migraines / headaches/ migraine").In (b)(6) 2009, the patient experienced alopecia ("hair loss/ hair loss").In (b)(6) 2010, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)/ dyspareunia (painful sexual intercourse)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)") and tooth disorder ("dental problems/ dental problems").In (b)(6) 2013, the patient experienced mood swings ("hormonal changes describe: mood swings"), depression ("psychological or psychiatric problems condition: depression, anxiety/ psych injury") and anxiety ("psychological or psychiatric problems condition: depression, anxiety/ psych injury").In (b)(6) 2014, the patient experienced ovarian cyst ("reproductive system disorder or condition type of disorder or condition: cyst on left ovary").In (b)(6) 2016, the patient experienced pelvic pain ("pelvic pain/ pelvic pain").In (b)(6) 2017, the patient experienced allergy to metals ("nickel allergy/ allergy: nickel post-essure") and dysgeusia ("allergic or hypersensitivity reaction type: metallic taste in mouth").In (b)(6) 2017, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/ dysmenorrhea (cramping)").In (b)(6) 2017, the patient experienced dermatitis acneiform ("rashes or skin conditions type: hives, rash, acne, itchy acne") and eczema ("rashes or skin conditions type: eczema") and was found to have weight decreased ("weight loss/ weight loss").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), vulvovaginal pain ("vaginal pain"), urticaria ("rashes or skin conditions type: hives, rash, acne/ rash/skin condition"), rash ("rashes or skin conditions type: hives, rash, acne/ rash/skin condition"), arthralgia ("joint aches"), headache ("headache/ headaches"), abdominal pain ("abdominal pain") and hypersensitivity ("hypersensitivity").Essure treatment was not changed.At the time of the report, the genital haemorrhage, pelvic pain, vulvovaginal pain, vaginal haemorrhage, menorrhagia, allergy to metals, dysmenorrhoea, dyspareunia, mood swings, abdominal distension, urticaria, rash, dysgeusia, female sexual dysfunction, depression, anxiety, dermatitis acneiform, migraine, ovarian cyst, tooth disorder, weight decreased, alopecia, arthralgia, headache, abdominal pain, hypersensitivity and eczema outcome was unknown.The reporter considered abdominal distension, abdominal pain, allergy to metals, alopecia, anxiety, arthralgia, depression, dermatitis acneiform, dysgeusia, dysmenorrhoea, dyspareunia, eczema, female sexual dysfunction, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, mood swings, ovarian cyst, pelvic pain, rash, tooth disorder, urticaria, vaginal haemorrhage, vulvovaginal pain and weight decreased to be related to essure.The reporter commented: discrepancy- date(s) of insertion: (b)(6) 2008 (per pfs-updated), nov-2008 diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 41.7 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 5-dec-2019: pfs received.Rash updated to rashes or skin conditions type: itchy acne.Event eczema added.New reporters, concomitant condition, drug and historical drug added.

• 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: 9531414
• MDR Text Key: 183427201
• Report Number: 2951250-2019-14866
• 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: 12/30/2019

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: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• 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
• Patient Weight: 117