FDA Adverse Event Injury Summary report: N

REALITY CONDOMS

MDR report key: 12058706 · Received June 23, 2021

Report

Report Number
MW5102111
Event Type
Injury
Date Received
June 23, 2021
Date of Event
July 15, 2009
Report Date
June 15, 2021
Manufacturer
THE FEMALE HEALTH CO.
Product Code
MBU
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

HAD TO GO PERIODIC VAGINAL SCREENINGS HAD 2 PREVIOUSLY TUBAL LIGATIONS. IMPLANTED ON (B)(6) 1993, EXPLANTED ON (B)(6) 2009.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
951351 REALITY CONDOMS SINGLE-USE INTERNAL CONDOM MBU THE FEMALE HEALTH CO.

Patients

Seq Age Sex Outcome Treatment
1 30 YR Required Intervention