FDA Adverse Event
Other
Summary report: N
ALLDAYS PANTY LINERS
MDR report key: 1012995
·
Received March 11, 2008
Report
- Report Number
- 8022168-2008-00001
- Event Type
- Other
- Date Received
- March 11, 2008
- Date of Event
- January 22, 2008
- Report Date
- March 6, 2008
- Manufacturer
- PROCTER & GAMBLE, INC.
- Product Code
- HHD
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CONSUMER WAS ASKED TO RETURN UNUSED PRODUCT FROM THE SAME PACKAGE. THE PRODUCT HAS NOT YET BEEN RETURNED FOR EVAL.
Description of Event or Problem · 1
CONSUMER STATED THAT SHE HAD SUCH A BAD RASH THAT SHE WAS SWOLLEN BEYOND RECOGNITION. SHE WENT TO THE EMERGENCY ROOM AND STATED THAT SHE HAS BEEN SICK FOR OVER 2 WEEKS. THE CONSUMER STATED THAT THE PAIN WAS WORSE THAN CHILDBIRTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLDAYS PANTY LINERS | MENSTRUAL PADS, UNSCENTED | HHD | PROCTER & GAMBLE, INC. | NA | 73224786760036A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |