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

Medical Device Problem Codes	Device Emits Odor (1425); Product Quality Problem (1506)
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943)
Date of Event	02/04/2023
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PROCTER & GAMBLE CO.; cincinnati OH
• MDR Report Key: 16364490
• Report Number: MW5114890
• Device Sequence Number: 7548935
• Product Code: HHD
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2023
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White