MAUDE Adverse Event Report: NATURALENA BRANDS INC. VEEDA NATURAL COTTON TAMPON; SUPER VEEDA NATURAL COTTON TAMPON

Lot Number 1507687/189/2

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problems Irritation (1941); Pain (1994); Foreign Body In Patient (2687)

Event Date 05/01/2017

Event Type  Injury  

Event Description

This is a feminine tampon.The tampon was very loosely wrapped and left cotton sticking to my body.It was very irritating to the skin, and it left cotton stuck inside the body and it left fuzzy cotton sticking to the outside of my body.I tried a few of those from the same box and experienced consistently bad results, and increasing feminine irritation.I fear this could lead to health concerns.This could be particularly bad if fibers are left inside the body and if they happen to irritate or stick to the cervix or other female organs.I also read a review from someone else that said this brand of tampon tore in half inside her body and she had difficulty removing the remaining half that was left inside her body.Also the tampons do not work.They are painful to use, and they leak without absorbing as they should.Because the product falls apart, i fear this product is harmful and is not safe for women to use.I called the company and left two voice messages about this and they did not call me back.

• Brand Name: VEEDA NATURAL COTTON TAMPON
• Type of Device: SUPER VEEDA NATURAL COTTON TAMPON
• Manufacturer (Section D): NATURALENA BRANDS INC.
• MDR Report Key: 6553865
• MDR Text Key: 74826988
• Report Number: MW5069639
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 10462020016
• UDI-Public: 10462020016
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/30/2020
• Device Lot Number: 1507687/189/2
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability