FDA Adverse Event
Injury
Summary report: N
TROJAN, FIRE & ICE SUB BRAND
MDR report key: 2017334
·
Received March 9, 2011
Report
- Report Number
- 2280705-2011-00012
- Event Type
- Injury
- Date Received
- March 9, 2011
- Report Date
- March 11, 2011
- Manufacturer
- CHURCH & DWIGHT CO., INC.
- Product Code
- HIS
- PMA / PMN Number
- K912901
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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 PHONE, "MY WIFE HAS BEEN TO THE DOCTOR SEVERAL TIMES BECAUSE OF .... INFECTION AND BLEEDING IN HER VAGINA....[ALSO] SOME REDNESS FOLLOWED BY IRRITATION ON MY PENIS." ACCORDING TO CONSUMER, USE OF THE PRODUCT WAS AROUND (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROJAN, FIRE & ICE SUB BRAND | MALE LATEX CONDOM, SECTION884.5300 | HIS | CHURCH & DWIGHT CO., INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |