MAUDE Adverse Event Report: NATRACARE NATURACARE ORGANIC AND NATURAL PANTYLINERS BOX OF 30 COUNT CURVED; PERSONAL PROTECTION

Model Number 1414246

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)

Event Date 03/09/2015

Event Type  Other  

Event Description

(b)(4).I used naturacare pantyliner for 3 days and developed an allergic skin reaction with severe acute blisters where the pantyliner adhesive touched my skin.I went to dermatologist for help and diagnosis and confirmed it was an allergic reaction.I am allergic to methylisothiazolinone and it must be in the adhesive at a high enough concentration to elicit a reaction.The blisters are not going away.Mfr: natracare llc, body wise ((b)(4)) ltd made in (b)(4).Retailer: (b)(6).Explanation: they are not answering adhesive ingredients.

• Brand Name: NATURACARE ORGANIC AND NATURAL PANTYLINERS BOX OF 30 COUNT CURVED
• Type of Device: PERSONAL PROTECTION
• Manufacturer (Section D): NATRACARE; greeley CO 80634 185
• MDR Report Key: 4643321
• MDR Text Key: 5752798
• Report Number: MW5041666
• Device Sequence Number: 1
• Product Code: HHD
• 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: 03/12/2015

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: Other
• Device Model Number: 1414246
• Other Device ID Number: 141246
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2015
• Patient Sequence Number: 1
• Patient Age: 46 YR