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
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/10/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): TARGET GENERAL MERCHANDISE INC.; 33 south sixth street; mailstop cc-3403; minneapolis MN 55402
• MDR Report Key: 13282369
• Report Number: MW5106688
• Device Sequence Number: 4900594
• Product Code: HEB
• UDI-Device Identifier: 00834533001131
• UDI-Public: 834533001131
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 254040284 R00 C-001227-01-094
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MELATONIN
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White