FDA Adverse Event Injury Summary report: N

TROJAN ULTRA THIN CONDOMS

MDR report key: 17254198 · Received July 5, 2023

Report

Report Number
2280705-2023-01018
Event Type
Injury
Date Received
July 5, 2023
Report Date
July 3, 2023
Manufacturer
CHURCH & DWIGHT CO., INC
Product Code
HIS
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

THIS SPONTANEOUS REPORT (2023-CDW-01018, 007798811A) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A 39-YEAR-OLD FEMALE CONSUMER WHO DEVELOPED HERPES AFTER USING THE TROJAN ULTRA THIN CONDOMS. THE CONSUMER'S MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER USED TROJAN ULTRA THIN CONDOMS. AFTER USING THE CONDOM, SHE DEVELOPED HERPES. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ACTION TAKEN WITH THE TROJAN ULTRA THIN CONDOMS WAS NOT APPLICABLE. THE OUTCOME OF THE EVENT WAS UNKNOWN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1932158 TROJAN ULTRA THIN CONDOMS CONDOM HIS CHURCH & DWIGHT CO., INC

Patients

Seq Age Sex Outcome Treatment
1 39 YR Female Other