MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLPEARLJRLITES; TAMPON, MENSTRUAL, SCENTED

Lot Number 0210243049W, 0236243049W

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

A product investigation is in progress.

Event Description

Tampon fell apart, and a piece of cotton remained inserted, foreign body in reproductive tract, tampon fell apart, device breakage.Case description: consumer contacted via e-mail and stated that twice after she used a tampon, it fell apart, and a piece of cotton remained inserted.No serious injury was reported.

Event Description

Tampon fell apart and a piece of cotton remained inserted [foreign body in reproductive tract].Tampon fell apart [device breakage].Consumer contacted via e-mail and stated that twice after she used a tampon, it fell apart and a piece of cotton remained inserted.No serious injury was reported.

Manufacturer Narrative

04-dec-2020 product investigation results: no failure could be identified as a result of the investigation.

• Brand Name: TAMPAXTAMPONSPEARLPEARLJRLITES
• Type of Device: TAMPON, MENSTRUAL, SCENTED
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn ME 04210
• MDR Report Key: 11029153
• MDR Text Key: 222674883
• Report Number: 1219109-2020-00418
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): N
• PMA/PMN Number: K081555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 0210243049W, 0236243049W
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1