MAUDE Adverse Event Report: NATRACARE PANTYLINERS; CURVED LINERS BOX OF 30

Catalog Number 1414246

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Injury (2348)

Event Date 03/09/2015

Event Type  Injury  

Event Description

Reaction to adhesives in personal care feminine panty liners (feminine napkins) where skin became blistered.Dates of use: (b)(6) 2015.

• Brand Name: NATRACARE PANTYLINERS
• Type of Device: CURVED LINERS BOX OF 30
• MDR Report Key: 4613518
• MDR Text Key: 5655264
• Report Number: MW5041497
• Device Sequence Number: 1
• Product Code: HHD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/12/2015

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
• Device Operator: Other
• Device Catalogue Number: 1414246
• Device Lot Number: 6087278 PZN
• Other Device ID Number: 03/09/2014
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2015
• Patient Sequence Number: 1
• Treatment: RX MEDS: TOPICAL LIGHT THERAPY ONE HANDS ONLY; OTC MEDS: VITAMIN C, ADVIL
• Patient Outcome(s): Other; Disability
• Patient Age: 46 YR
• Patient Weight: 73