MAUDE Adverse Event Report: PROCTER & GAMBLE CO. ALWAYS MAXI SANITARY NAPKINS; PAD, MENSTRUAL, UNSCENTED

Device Problems Device Emits Odor (1425); Product Quality Problem (1506)

Patient Problems Erythema (1840); Itching Sensation (1943)

Event Date 02/04/2023

Event Type  malfunction  

Event Description

Attention, due to its content this message is to be seen from a woman only, please and thanks; on (b)(6) 2023 i purchased a package with 36 pads always maxi sanitary pads for menstrual cycle.These were 100% leak-free.I purchased those at (b)(6).Each one of these pads had and has a chemical plastic odor on it and they made me itch and caused redness on my skin while i used them.Please inspect these sanitary pads and do what is needed to be done.Should you have any questions and also to confirm that you received this message, please call me at (b)(6).Thanks.

• Brand Name: ALWAYS MAXI SANITARY NAPKINS
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PROCTER & GAMBLE CO.; cincinnati OH
• MDR Report Key: 16364490
• MDR Text Key: 309515064
• Report Number: MW5114890
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): N
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2023
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White