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