CARE FREE ORIGINAL PANTY LINERS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-10 for CARE FREE ORIGINAL PANTY LINERS manufactured by Edgewell Personal Care Brands, Llc/playtex.

Event Text Entries

[123941093] Good morning, i have used carefree pantiliners for years and recently noted a few weeks ago as i was getting ready to use one, i noticed a very disturbing significant discoloration on that liner as well as another one in the bag. There was only one other remaining in that bag which appeared to be intact. Nonetheless i'm very frightened and concerned potential exposure to infectious process as a having had recently experienced a vaginal infection. Please note, i cannot recall the last time this has occurred. I have contacted the carefree company immediately that morning. I have agreed to give them one of the liners with a packaging back for them to examine it. I have also been treated by my gyn for a vaginal infection and do require f/u for this. Thank you so much for your time. (b)(6). Other serious/important medical incident: required to see my gyn. Otc product. The problem did not stop after the person reduced the dose or stopped taking or using the product. Date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018. "how was it taken or used: vaginal liners. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5080477
• MDR Report Key: 7956795
• Date Received: 2018-10-10
• Date of Report: 2018-10-09
• Date of Event: 2018-09-22
• Date Added to Maude: 2018-10-11
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CARE FREE ORIGINAL PANTY LINERS
• Generic Name: PADS, MENSTRUAL,UNSCENTED
• Product Code: NRC
• Date Received: 2018-10-10
• Lot Number: 1814905187
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EDGEWELL PERSONAL CARE BRANDS, LLC/PLAYTEX

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-10-10