FDA Adverse Event
Injury
Summary report: N
TROJAN PLEASURE PACK
MDR report key: 2010601
·
Received March 1, 2011
Report
- Report Number
- 2280705-2011-00007
- Event Type
- Injury
- Date Received
- March 1, 2011
- Report Date
- March 2, 2011
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- HIS
- PMA / PMN Number
- K912901
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SHE LATER STATED THAT SHE USED FIRE & ICE SUB BRAND, BUT DID NOT PROVIDE INFO TO CONFIRM WHETHER FIRE & ICE PRODUCT IS DIRECTLY ASSOCIATED WITH THIS COMPLAINT. FOR FURTHER EVAL, CHURCH & DWIGHT CO., INC. HAS REQUESTED THE FOLLOWING FROM THE USER: THE PRODUCT, ITS ORIGINAL PACKAGING, AND COMPLETION OF AN EVENT QUESTIONNAIRE. TO DATE, THE REQUESTED HAS NOT YET BEEN RETURNED.
Description of Event or Problem · 1
ON (B)(6) 2011, A CONSUMER REPORTED BY EMAIL THAT SHE HAD "A DIAGNOSED YEAST INFECTION." HOWEVER, ON (B)(6) 2011, THE CONSUMER SENT AN UPDATE EMAIL THAT STATED "RATHER THAN GETTING A YEAST INFECTION LIKE ORIGINALLY TOLD BY THE DR, I HAVE A URINARY TRACT INFECTION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROJAN PLEASURE PACK | MALE LATEX CONDOM SECTION 884.5300 | HIS | CHURCH & DWIGHT CO., INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |