MAUDE Adverse Event Report: EQUATE SUPER MAXI PADS; MENSTRUAL SANITARY PADS

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 12/10/2018

Event Type  Injury  

Event Description

Menstrual sanitary pads caused me to have mild/moderate vaginal chemical burns.They don't have an ingredients list so there's no way to tell what the irritant was.Dates of use: (b)(6) 2018.Diagnosis or reason for use: mild incontinence.Is the product over-the-counter? yes; event abated after use stopped or dose reduced? yes; event reappeared after reintroduction? yes.

• Brand Name: EQUATE SUPER MAXI PADS
• Type of Device: MENSTRUAL SANITARY PADS
• MDR Report Key: 8155415
• MDR Text Key: 130313962
• Report Number: MW5082065
• 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: 12/10/2018

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR
• Patient Weight: 50