MAUDE Adverse Event Report: WALGREEN CO. PANTILINERS; PAD, MENSTRUAL, UNSCENTED

Catalog Number 214997

Device Problem Device Emits Odor (1425)

Patient Problems Nausea (1970); Discomfort (2330); Skin Inflammation/ Irritation (4545)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

I purchased "walgreens pantiliners in the purple cartoon box 40 liners protectores sensadry coversheet compare to always", it is a pack with 40(forty) of these pantyliners long.They had a bad odor.I had a box like that before and i had notified walgreens about it, but they did nothing to handle the issue of the bad odor to the point that caused me to have nausea.Also these pantyliners are the not absorbent and they cause skin irritation and discomfort while using them.

• Brand Name: PANTILINERS
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): WALGREEN CO.
• MDR Report Key: 15869821
• MDR Text Key: 304508154
• Report Number: MW5113500
• 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: 11/22/2022

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
• Device Catalogue Number: 214997
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/25/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White