MAUDE Adverse Event Report: UNKNOWN TAMPAX PEARL SUPER PLUS SCENTED TAMPONS

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Anxiety (2328); Fungal Infection (2419)

Event Date 12/24/2017

Event Type  Injury  

Event Description

Tampax pearl super plus scented tampons gave me a recurrent yeast infection after use.After i researched it online, it is well known that scented tampons lead to bacterial vaginosis or yeast infections.Such products should not be on the market as yeast infections are embarrassing, anxiety inducing, and stressful to deal with while living a professional life.Date the person first started taking or using the product: (b)(6) 2017.Date the person stopped taking or using the product: (b)(6) 2017.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Did the problem return if the person started taking or using the product again: yes.Do you still have the product in case we need to evaluate it: yes.Why was the person using the product: menstruation.

• Brand Name: TAMPAX PEARL SUPER PLUS SCENTED TAMPONS
• Type of Device: TAMPAX PEARL SUPER PLUS SCENTED TAMPONS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 7168598
• MDR Text Key: 96694275
• Report Number: MW5074419
• Device Sequence Number: 0
• Product Code: HIL
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 54