MAUDE Adverse Event Report: TOPCO ASSOCIATES LLC TOP CARE EVERYDAY USE TAMPONS; TAMPON, MENSTRUAL, UNSCENTED

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/23/2021

Event Type  malfunction  

Event Description

Top care 'everyday' regular absorbency tampon unravelled and fell apart inside vagina during attempted removal at 4 hours of wear.Family fare, top care.

• Brand Name: TOP CARE EVERYDAY USE TAMPONS
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): TOPCO ASSOCIATES LLC; 150 northwest point blvd.; elk grove village IL 60007
• MDR Report Key: 13093442
• MDR Text Key: 282909139
• Report Number: MW5106288
• Device Sequence Number: 1
• Product Code: HEB
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: IRON
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White