ALWAYSPADSULTRATHINULTRABASEVERWINGLONGNONDO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-07 for ALWAYSPADSULTRATHINULTRABASEVERWINGLONGNONDO manufactured by Procter & Gamble Inc.

Event Text Entries

[81919607] Return of product has been requested. A lot number was provided by the reporter. Full evaluation will occur upon receipt of returned product. This case was initially submitted on 31-may-2017 with the incorrect mfr report # of 8022158-2017-00001. This corrected initial submission has the accurate mfr report number.
Patient Sequence No: 1, Text Type: N, H10


[81919608] Bladder infection [cystitis], urinary tract infection [urinary tract infection], urinating blood [haematuria], allergic to the pads [hypersensitivity], spotted red rash all over private area-female genital [genital rash], burning sensation all over private area-female genital [genital burning sensation], itching all over private area-female genital [pruritus genital], rash in pad area [medical device site rash], burning sensation in pad area [medical device site paraesthesia], itching in pad area [medical device site pruritus], allergic broke out from pads [medical device site hypersensitivity]. Case description: a (b)(6) female consumer reported via phone on (b)(6) 2017 that she used always pads ultra thin ultra base version wing long non deodorant 1 pad, 4 times a day ending two and half weeks ago on (b)(6) 2017 and she was allergic to them. She clarified that she initially experienced a red spotted rash in the area of the pad (genital/private area), had a burning sensation, and itching. She asserted that on the third day of experiencing the rash, she started urinating blood, called her physician, who advised her to go to the emergency room. According to the consumer, she was admitted to the hospital for four days with a bladder infection and urinary tract infection. Treatment consisted of antibiotics intravenously while in the hospital. Also, she had to go back to the hospital for intravenous antibiotics as an outpatient afterwards. Product use was discontinued. The case outcome was recovered. Relevant history: allergy: allergic to some laundry soap; drug allergies: allergic to lots of medications. Concomitant product(s): none reported. Other product used previously: yes, had used always infinity pads and broke out in genital rash. Exact product used previously: yes. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8022168-2017-00001
MDR Report Key6770131
Report SourceCONSUMER
Date Received2017-08-07
Date of Report2017-05-12
Date Mfgr Received2017-07-07
Date Added to Maude2017-08-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMGR. REGULATORY FEMININE CARE
Manufacturer Street6110 CENTER HILL AVENUE
Manufacturer CityCINCINNATI OH 45224
Manufacturer CountryUS
Manufacturer Postal45224
Manufacturer G1PROCTER & GAMBLE INC
Manufacturer Street365 UNIVERSITY AVE
Manufacturer CityBELLEVILLE, ON K8N5E9
Manufacturer CountryCA
Manufacturer Postal CodeK8N5E9
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALWAYSPADSULTRATHINULTRABASEVERWINGLONGNONDO
Generic NamePAD, MENSTRUAL, UNSCENTED
Product CodeHHD
Date Received2017-08-07
Lot Number61837786401830283
ID NumberNOT AVAILABLE
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPROCTER & GAMBLE INC
Manufacturer Address365 UNIVERSITY AVE BELLEVILLE, ON K8N5E9 CA K8N5E9


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2017-08-07

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