MAUDE Adverse Event Report: PROCTER & GAMBLE INC. ALWAYS PURE COTTON WITH FEX FOAM; PAD, MENSTRUAL, UNSCENTED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction to Medicinal Component of Device (4574)

Event Type  No Answer Provided  

Event Description

Adverse reaction after using menstrual pad.

• Brand Name: ALWAYS PURE COTTON WITH FEX FOAM
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PROCTER & GAMBLE INC.
• MDR Report Key: 12689334
• MDR Text Key: 278572727
• Report Number: MW5104921
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1