FDA Adverse Event
Malfunction
Summary report: N
TROJAN PLEASURE PACK CONDOMS 12 CT
MDR report key: 13942494
·
Received March 29, 2022
Report
- Report Number
- 2280705-2022-00012
- Event Type
- Malfunction
- Date Received
- March 29, 2022
- Date of Event
- March 21, 2022
- Report Date
- March 29, 2022
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- HIS
- UDI-DI
- 00022600953029
- PMA / PMN Number
- K912901
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR CHURCH & DWIGHT CO., INC. OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HERE IN OR THAT THE EVENT AS REPORTED TO CHURCH & DWIGHT ACTUALLY OCCURRED.
Description of Event or Problem · 0
THE CONSUMER CLAIMS TO BE AN ESCORT AND ALLEGES THAT THE TROJAN CONDOM BROKE. SHE STATES THAT SHE NOW HAS TO FIND A CLINIC. THIS EVENT IS REPORTABLE BASED ON THE ALLEGATION OF A PRODUCT MALFUNCTION, WITH THE POTENTIAL EXPOSURE TO AN STD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1072600 | TROJAN PLEASURE PACK CONDOMS 12 CT | CONDOM | HIS | CHURCH & DWIGHT CO., INC. | 2260095302 | TT1143B | 00022600953029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |