FDA Adverse Event
Injury
Summary report: N
STAYFREE DEODORANT MAXI
MDR report key: 1546401
·
Received November 25, 2009
Report
- Report Number
- 8022269-2009-00005
- Event Type
- Injury
- Date Received
- November 25, 2009
- Date of Event
- November 10, 2009
- Report Date
- November 12, 2009
- Manufacturer
- JOHNSON & JOHNSON INC.
- Product Code
- HHL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL SIGNIFICANT INFO IS RECEIVED.
Description of Event or Problem · 1
PT REPORTED USING THE PRODUCT 3 TIMES IN 2009. SHE WAS HOSPITALIZED DUE TO A URINARY TRACT INFECTION AND KIDNEY INFECTION, AND TREATED WITH BACTRIM AND CIPROFLOXACIN AND IV FLUIDS. THE DOCTOR STATED THAT THE INFECTION WAS RELATED TO THE DEODORANT IN THE PAD. SHE WAS HOSPITALIZED FOR 3 - 4 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAYFREE DEODORANT MAXI | MENSTRUAL PAD, SCENTED | HHL | JOHNSON & JOHNSON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization |