FDA Adverse Event Injury Summary report: N

TROJAN LATEX LUBRICATED CONDOM UNSPECIFIED

MDR report key: 15273831 · Received August 23, 2022

Report

Report Number
2280705-2022-01026
Event Type
Injury
Date Received
August 23, 2022
Report Date
July 18, 2022
Manufacturer
CHURCH & DWIGHT CO., INC.
Product Code
HIS
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

THIS SPONTANEOUS REPORT (2022-CDW-01026, 007581225A) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A CONSUMER (AGE AND GENDER UNSPECIFIED) WHOSE ONE OF THE CONDOMS BROKE AND DEVELOPED ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) COINCIDENT WITH TROJAN LATEX LUBRICATED CONDOM UNSPECIFIED. THE CONSUMER'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER INITIATED TROJAN LATEX LUBRICATED CONDOM UNSPECIFIED (LOT NUMBER: UNKNOWN). THE CONSUMER STATED THAT ONE OF THE CONDOMS GOT BROKE, AND THE CONSUMER DEVELOPED AIDS. LATER, THE CONSUMER SWITCHED TO DUREX. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ACTION TAKEN WITH TROJAN LATEX LUBRICATED CONDOM UNSPECIFIED WAS WITHDRAWN. THE OUTCOME OF THE EVENT AIDS WAS UNKNOWN. THE OUTCOME OF THE EVENT ONE OF THE CONDOMS BROKE WAS NOT APPLICABLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2594831 TROJAN LATEX LUBRICATED CONDOM UNSPECIFIED CONDOM HIS CHURCH & DWIGHT CO., INC.

Patients

Seq Age Sex Outcome Treatment
1 Unknown Other