MAUDE MDR 3472049

MDR report key
3472049
Report number
8022168-2013-00001
Event key
0
Event type
3
Date of event
2013-10-15
Date received
2013-10-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Address
6110 CENTER HILL AVENUE WINTON HILL BUSINESS CTR CINCINNATI OH 45224 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALWAYS MAXI PAD, OVERNIGHT UNSCENTEDNONEPROCTER & GAMBLE, INC.HHD3213478600342130630N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-10-3001. O

Event Narratives#

D

Patient 1

ALLERGIC REACTION [HYPERSENSITIVITY]. THROAT SWELLING, AIRWAY CLOSING UP [PHARYNGEAL OEDEMA]. TONGUE STARTED FEELING FUNNY THEN HAD TONGUE SWELLING [SWOLLEN TONGUE]. LIPS SWELLING [LIP SWELLING]. HANDS AND FEET STARTED TO ITCH [PRURITUS]. CASE DESCRIPTION: A MAN REPORTED THAT HIS WIFE, AGE UNSPECIFIED, USED ALWAYS MAXI PAD, OVERNIGHT UNSCENTED PAD, FOR THE FIRST TIME, 1 APPLIC, 1 ONLY ON (B)(6) 2013 AND WITHIN SECONDS OF APPLICATION SHE HAD AN ALLERGIC REACTION WHERE HER HANDS AND FEET STARTED TO ITCH, TONGUE STARTED TO FEEL FUNNY THEN SHE HAD SWELLING OF HER LIPS, TONGUE AND THROAT AND HER THROAT WAS CLOSING UP TO THE POINT THAT SHE HAD DIFFICULTY TALKING. WITHIN FIFTEEN MINS, HER HUSBAND TOOK HER TO A DOCTOR'S OFFICE CLOSE TO A HOSPITAL WHERE AN EPI-PEN AND ANOTHER UNSPECIFIED SHOT WAS ADMINISTERED TO STOP THE SWELLING. HER HUSBAND MENTIONED THAT SHE STARTED SHAKING AFTER THE EPI-PEN WAS ADMINISTERED BUT WITHIN TEN MINUTES AFTER THE SHOT WAS ADMINISTERED HIS WIFE WAS ALMOST BACK TO NORMAL. HIS WIFE WAS GIVEN THREE PRESCRIPTIONS: EPI PEN, LORATADINE AND METHYLPREDNISOLONE. SHE DISCONTINUED USE OF THE PRODUCT AND USED THE PADS THAT SHE USED PREVIOUSLY. THE CASE OUTCOME WAS RECOVERED. PAST MEDICAL HISTORY INCLUDED: ALLERGY - NONE. CONCOMITANT MEDICATIONS INCLUDED: ANTIHYPERTENSIVES. NO FURTHER INFO WAS PROVIDED.

N

Patient 1

LOT NUMBER (3213478600342130630) PROVIDED BY THE REPORTER, PRODUCT REQUESTED BUT NOT RECEIVED TO DATE. PRODUCT AND LOT NUMBER INVESTIGATION PENDING.