ALWAYS INFINITY PAD OVERNIGHT UNSCENTED WITH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-18 for ALWAYS INFINITY PAD OVERNIGHT UNSCENTED WITH manufactured by Proctor And Gamble.

Event Text Entries

[4179609] I used an "always infinity overnight unscented pad with wings" overnight ((b)(6) 2014) and woke up to a chemical burn ((b)(6) 2014) covering the area that the pad touched. My skin was raw, peeling, inflamed, stinging, and very painful. I stopped using the pad immediately and switched to my cloth pads. Over the course of the next few days my skin went from red and inflamed to black, it then scabbed over, the scab then peeled off to reveal red, raw, skin, it then started peeling like a sunburn. I was applying soothing otc creams myself during this time, but on monday (b)(6) 2014 it was not any better and was in fact spreading even though i had not used the disposable pad since the initial onset of symptoms. I contacted my ob/gyn who prescribed a topical burn cream - silver sulfadiazine - and an oral anti-inflammatory - methyipredisolone. As of today, (b)(6) 2014, my symptoms still persist and the area does not seem to be shrinking and is still red and raw. I have contacted the company directly to report my symptoms.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5034596
MDR Report Key	3639439
Date Received	2014-02-18
Date of Report	2014-02-12
Date of Event	2014-02-05
Date Added to Maude	2014-02-24
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	PATIENT
Health Professional	0
Initial Report to FDA	3
Report to FDA	0
Event Location	0
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	ALWAYS INFINITY PAD
Generic Name	ALWAYS INFINITY PAD
Product Code	HHD
Date Received	2014-02-18
Model Number	OVERNIGHT UNSCENTED WITH
Lot Number	3181478600 68 181 1635
Device Sequence No	1
Device Event Key	0
Manufacturer	PROCTOR AND GAMBLE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-02-18