MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ PLAYTEX STAYFREE SUPER MAXIPAD

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

Patient Problems Erythema (1840); Irritation (1941); Pain (1994); Swelling (2091)

Event Date 04/18/2018

Event Type  Injury  

Event Description

Patient's husband purchased stayfree maxipad on (b)(6) and his wife has used the product for 4 days.On the 4th day, patient experienced severe pain, redness, irritation and swelling on bilateral thigh and labia.She has not seen physician due to fear and apprehension of doctors as well as no medical insurance.All symptoms have decreased, but has not completely gone away.

• Brand Name: STAYFREE SUPER MAXIPAD
• Type of Device: MAXIPAD
• Manufacturer (Section D): JOHNSON AND JOHNSON/ PLAYTEX
• MDR Report Key: 7540474
• MDR Text Key: 109236401
• Report Number: MW5077434
• 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: 05/23/2018

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 113