MAUDE Adverse Event Report: PROCTOR AND GAMBLE ALWAYS INFINITY PAD

Model Number OVERNIGHT UNSCENTED WITH

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932); Pain (1994); Peeling (1999); Skin Discoloration (2074); Caustic/Chemical Burns (2549)

Event Date 02/05/2014

Event Type  Injury  

Event Description

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.

• Brand Name: ALWAYS INFINITY PAD
• Type of Device: ALWAYS INFINITY PAD
• Manufacturer (Section D): PROCTOR AND GAMBLE
• MDR Report Key: 3639439
• MDR Text Key: 4179609
• Report Number: MW5034596
• Device Sequence Number: 1
• Product Code: HHD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: OVERNIGHT UNSCENTED WITH
• Device Lot Number: 3181478600 68 181 1635
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Weight: 84