Up&Up Tampons 245-04-0284Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00834533001131), received between Jan 14, 2022 and Jan 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2022Material Fragmentation

  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).

  Patient problems: Unspecified Infection

  MAUDE report 13282369 ↗