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

Model Number ESSURE ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Autoimmune Reaction (1733); Bruise/Contusion (1754); Headache (1880); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Depression (2361); Sweating (2444); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)

Event Date 10/08/2009

Event Type  Injury  

Event Description

Implanted with essure device and ablation performed after implantation which not warned to be contraindicated.Was not informed about adverse reactions to materials.Allergy test not performed.Side effects: extreme painful bloating immediate-9 yrs, pelvic pain, abdominal pain, painful menstruation (which should not occur due to the thin lining after ablation, including passing clots and tissue; ovarian pain, auto immune symptoms with positive labs oa, migraines, rashes, extreme sweating, foggy brain, memory loss; bleeding gums.Blood blisters, bruising, skin rashes, flushing, insomnia, depression, lead to hysterectomy including ovaries and cervix to properly remove the essure coils.Coils had not migrated but one could be seem unsheathing from the fallopian tube.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7645357
• MDR Text Key: 112747945
• Report Number: MW5078108
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/25/2018

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: Lay User/Patient
• Device Expiration Date: 05/30/2012
• Device Model Number: ESSURE ESS305
• Device Lot Number: 645019
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 51 YR
• Patient Weight: 54