FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 3900370 · Received June 27, 2014

Report

Report Number
MW5036860
Event Type
Injury
Date Received
June 27, 2014
Date of Event
June 24, 2014
Report Date
June 24, 2014
Manufacturer
BAYER
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ALLERGIES, MIGRAINES, PAIN IN LOWER BACK, PAIN IN RIGHT SIDE OF THE ABDOMEN, HAIR LOSS, ACNE, GAIN WEIGHT, SWOLLEN FEET, MENSTRUAL PROBLEMS, DEPRESSION. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
376625 ESSURE HHS BAYER

Patients

Seq Age Sex Outcome Treatment
1 32.000 YR Hospitalization| O| S