Medical Device Reporting (MDR)

The Medical Device Reporting pursuant to the (21 CFR 803) contains mandatory requirements for manufacturers, importers and user facilities to report significant medical device adverse events to the Food and Drug Administration (FDA). FDA uses this information to identify and respond to problems associated with medical devices.

There is also a voluntary MedWatch program for consumers or healthcare professionals to use to voluntarily report significant adverse events or product problems with medical products to FDA.

Essure

Essure is a permanent birth control method for women (female sterilization). A health care provider inserts soft, flexible coils into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus.

Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception.

Essure is considered a permanent form of birth control and therefore is not intended to be removed. (read more here)

Medical Device Reports (MDRs) Reported to the FDA for a Permanent Contraceptive Medical Device (Essure)

From February 1, 2016 through February 29, 2016

The FDA’s database (MAUDE) was searched for Brand Name “Essure.” The search output reveals 451 records. 417 records out of 451 records relate to Essure.

The Bayer Healthcare LLC has reported eight five (85) medical device reports (MDRs). Others have reported 332 MDRs, totaling 417 MDR reports based on all event types including death, injury, malfunction, other, and no answer provided. The following shows summary of the search output.

MDRs for Essure-February 2016

Download the list in PDF

Download “2016-March-18-MDRs-for-Essure-February-2016.pdf” 2016-March-18-MDRs-for-Essure-February-2016.pdf – Downloaded 107 times – 215 KB

Last Updated: 2016-03-18

2016 February MDRs for Essure
Tagged on: