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 |