MAUDE Adverse Event Report: TARGET GENERAL MERCHANDISE INC. UP & UP COMPACT TAMPON 34 COUNT; TAMPON, MENSTRUAL, UNSCENTED

Model Number 254040284 R00 C-001227-01-094

Device Problem Material Fragmentation (1261)

Patient Problem Unspecified Infection (1930)

Event Date 10/10/2021

Event Type  Injury  

Event Description

I placed a tampon in before a birthday dinner.When i got home from celebrating the birthday, i went to replace my tampon.This regular sized tampon began to unravel inside of my vagina.I had to repeatedly pull out tiny pieces, it felt like it was never going to stop.I didn't worry about it, until i began to wonder if i got it all out.The following day (b)(6) 2021 symptoms on an infection began to appear.I went to the doctor on (b)(6) 2021 to make sure i got all the pieces of tampon out, there i was diagnosed with vaginitis.I took an antibiotic for this, and the infection came back a month later.Please note i have never had this infection previously.I have been in contact with "(b)(6)" since this problem started, but we have not gotten anywhere.Fda safety report id# (b)(4).

• Brand Name: UP & UP COMPACT TAMPON 34 COUNT
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): TARGET GENERAL MERCHANDISE INC.; 33 south sixth street; mailstop cc-3403; minneapolis MN 55402
• MDR Report Key: 13282369
• MDR Text Key: 284025643
• Report Number: MW5106688
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00834533001131
• UDI-Public: 834533001131
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 254040284 R00 C-001227-01-094
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: MELATONIN
• Patient Outcome(s): Disability
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White