ALWAYS INFINITY PAD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-12 for ALWAYS INFINITY PAD manufactured by Procter And Gamble.

Event Text Entries

[21540174] Rash/itchiness, severe irritation to area in contact with edges of feminine pad (question reaction to adhesive used in product).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5041503
• MDR Report Key: 4614033
• Date Received: 2015-03-12
• Date of Report: 2015-03-12
• Date of Event: 2015-02-19
• Date Added to Maude: 2015-03-19
• 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 Sequence Number: 1

• Brand Name: ALWAYS INFINITY PAD
• Generic Name: ALWAYS INFINITY PAD
• Product Code: HHD
• Date Received: 2015-03-12
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PROCTER AND GAMBLE

Device Sequence Number: 2

• Brand Name: ALWAYS ALL DAY PANTY LINER
• Generic Name: PANTY LINER
• Product Code: HHD
• Date Received: 2015-03-12
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: PROCTER AND GAMBLE

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-03-12