FDA Adverse Event
Injury
Summary report: N
TROJAN CONDOMS UNSPECIFIED
MDR report key: 17608831
·
Received August 23, 2023
Report
- Report Number
- 2280705-2023-01265
- Event Type
- Injury
- Date Received
- August 23, 2023
- Report Date
- August 24, 2023
- Manufacturer
- [email protected]
- 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-01265, 007835318A) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A CONSUMER (AGE AND GENDER UNSPECIFIED) WHO DEVELOPED ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AFTER USING TROJAN CONDOMS UNSPECIFIED. ON AN UNSPECIFIED DATE, THE CONSUMER USED TROJAN CONDOMS UNSPECIFIED DURING SEX. THE CONSUMER ALLEGED THAT THEY DEVELOPED AIDS AFTER USING A CONDOM. 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 EVENT USED THE PRODUCT AND GOT AIDS (DEVICE FAILURE) WAS NOT APPLICABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301203 | TROJAN CONDOMS UNSPECIFIED | CONDOM | HIS | [email protected] |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |