MAUDE Adverse Event Report: EDGEWELL PERSONAL CARE CAREFREE; PANTY LINERS, LONG, FLAT, UNSCENTED,

Lot Number	24176D8044
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer stated that she purchased a box of carefree liners about 2 weeks ago at a shoppers drug mart in (b)(6).Consumer stated that she ended up in the hospital for 2 weeks because the liners gave her skin irritation.Consumer stated that she is under doctor care due to this product.Consumer stated that she is not allergic to anything.

• Brand Name: CAREFREE
• Common Device Name: PANTY LINERS, LONG, FLAT, UNSCENTED,
• Manufacturer (Section D): EDGEWELL PERSONAL CARE; 804 walker rd; dover DE 19904
• Manufacturer Contact: kevin zhang ; 804 walker rd; dover, DE 19904
• MDR Report Key: 21583863
• Report Number: 2515444-2025-70004
• Device Sequence Number: 8938386
• Product Code: HHD
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Lot Number: 24176D8044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female