MAUDE Adverse Event Report: PROCTER AND GAMBLE ALWAYS INFINITY PAD

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Rash (2033); Reaction (2414)

Event Date 02/19/2015

Event Type  Injury  

Event Description

Rash/itchiness, severe irritation to area in contact with edges of feminine pad (question reaction to adhesive used in product).

• Brand Name: ALWAYS INFINITY PAD
• Type of Device: ALWAYS INFINITY PAD
• Manufacturer (Section D): PROCTER AND GAMBLE
• MDR Report Key: 4614033
• MDR Text Key: 21540174
• Report Number: MW5041503
• 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: 03/12/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2015
• Patient Sequence Number: 1
• Treatment: TRIAMCINOLONE CREAM; ZYRTEC
• Patient Age: 32 YR
• Patient Weight: 64