FDA Adverse Event
Injury
Summary report: N
TROJAN CONDOMS UNSPECIFIED
MDR report key: 17028791
·
Received May 31, 2023
Report
- Report Number
- 2280705-2023-00892
- Event Type
- Injury
- Date Received
- May 31, 2023
- Date of Event
- May 20, 2023
- Report Date
- May 23, 2023
- Manufacturer
- CHURCH & DWIGHT CO., IN
- Product Code
- HIS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THIS SPONTANEOUS REPORT (2023-CDW-00892, 007778474A) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A CONSUMER (AGE AND GENDER UNSPECIFIED) WHOSE CONDOM BROKE AND DEVELOPED ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AFTER USING THE TROJAN CONDOMS UNSPECIFIED. ON AN UNSPECIFIED DATE, THE CONSUMER USED TROJAN CONDOMS UNSPECIFIED. THE CONSUMER ALLEGED THAT THE CONDOM BROKE, AND THE CONSUMER GOT AIDS. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ACTION TAKEN WITH TROJAN CONDOMS UNSPECIFIED WAS NOT APPLICABLE. THE OUTCOME OF THE EVENT AIDS WAS UNKNOWN. THE OUTCOME OF THE CONDOM BREAKAGE WAS NOT APPLICABLE. NOTE: THE CONTACT WAS RECEIVED VIA INSTAGRAM, AND THE CONSUMER DID NOT RESPOND TO OUR REQUEST FOR FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1296585 | TROJAN CONDOMS UNSPECIFIED | CONDOM | HIS | CHURCH & DWIGHT CO., IN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |