FDA Adverse Event
Other
Summary report: N
ALWAYS/ALLDAYS PANTYLINER, SCENTED
MDR report key: 3185676
·
Received June 18, 2013
Report
- Report Number
- 9680085-2013-00001
- Event Type
- Other
- Date Received
- June 18, 2013
- Report Date
- May 27, 2013
- Manufacturer
- PROCTER & GAMBLE GMBH & CO.
- Product Code
- HHL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ALLERGIC REACTION [HYPERSENSITIVITY]. SWOLLEN [OEDEMA]. PUFFINESS FACE [SWELLING FACE]. COULDN'T BREATHE/SHORT OF BREATH [DYSPNOEA]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A FEMALE AGE UNSPECIFIED, USED ALWAYS/ALLDAYS PANTYLINER, SCENTED LINER TOTAL OF FOUR LINERS OVER A DAY AND A HALF BEGINNING (B)(6) 2013 AND REPORTED THE FOLLOWING: HAD AN ALLERGIC REACTION WHEN SHE WOKE UP (B)(6) 2013 SWOLLEN; FACE PUFFINESS AND COULD NOT BREATHE. THE CONSUMER VISITED HER PHYSICIAN AND RECEIVED FOUR CORTIZONE SHOTS. THE CASE OUTCOME WAS IMPROVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - UNSPECIFIED ALLERGIES, ASTHMA. CONCOMITANT MEDICATIONS INCLUDED: ALLERGY MEDICATION. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277285 | ALWAYS/ALLDAYS PANTYLINER, SCENTED | NONE | HHL | PROCTER & GAMBLE GMBH & CO. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |