MAUDE Adverse Event Report: CVS PHARMACY, INC. CVS HEALTH TAMPON; TAMPONS

Catalog Number 416639

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/14/2017

Event Type  malfunction  

Event Description

Tampon broke in body and i didn't know.I pulled out part of tampon with the sewn-in strong.At the time, i thought something was weird but couldn't figure out what.Two days later, realized foreign object was inside and then i pulled out huge chunk of tampon.

• Brand Name: CVS HEALTH TAMPON
• Type of Device: TAMPONS
• Manufacturer (Section D): CVS PHARMACY, INC.
• MDR Report Key: 6800874
• MDR Text Key: 82999201
• Report Number: MW5071640
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 416639
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 61