FDA Adverse Event
Injury
Summary report: N
TROJAN MAGNUM FIRE AND ICE
MDR report key: 2848307
·
Received November 21, 2012
Report
- Report Number
- 2280705-2012-00168
- Event Type
- Injury
- Date Received
- November 21, 2012
- Report Date
- November 21, 2012
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- HIS
- PMA / PMN Number
- K120287
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CHURCH AND DWIGHT CO., INC. HAS REQUESTED THE FOLLOWING FROM THE CONSUMER: THE PRODUCT, ITS ORIGINAL PACKAGING, AND THE COMPLETION OF AN EVENT QUESTIONNAIRE. TO DATE, THE REQUESTED PRODUCT AND ITS ORIGINAL PACKAGING HAVE NOT YET BEEN RETURNED.
Description of Event or Problem · 1
AS A RESULT OF USE OF PRODUCT, CONSUMER CALLED AND DESCRIBED COMPLETE LOSS OF FEELING IN HER VAGINAL AREA; LOSS OF FEELING REMAINED FOUR DAYS LATER. RETURN OF SENSATION HAS NOT BEEN CONFIRMED; THEREFORE, THIS IS BEING REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROJAN MAGNUM FIRE AND ICE | MALE LATEX CONDOM, SECTION 884.5300 | HIS | CHURCH & DWIGHT CO., INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |