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