Playtex 13518Recalls & reported problems
Edgewell Personal Care Brands, LLC · Playtex Sport 32ct S/S+ Multi-Pack · Class 2
All models of Playtex (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00078300135180), received between Jun 13, 2026 and Jun 13, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2026Break; Material Fragmentation
REPORTER MENTIONED THAT WHEN SHE APPLIED TAMPON IN THE MORNING, APPLICATION FELT A SLIGHT DISCOMFORT BUT SHE DIDNT INVESTIGATE THE CAUSE. THREE (3) HOURS LATER SHE WENT TO REMOVE THE TAMPON AND A SHARD OF THE APPLICATOR ALSO CAME OUT INTO THE TOILET. SHE THOUGHT IT WAS HER OWN FAULT AND DIDNT THINK ANYTHING ABOUT IT AFTER. LATER WHEN SHE APPLIED NEW TAMPON AND THE SAME THING HAPPENED, BUT THE SHARD LANDED IN HER HAND THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25495399 ↗
Other Tampon, menstrual, unscented devices
- U By Kotex KOTEX TAMPONSKimberly-Clark Global Sales, Inc. · Tampon, menstrual, unscented178 reports
- U By Kotex KOTEX TAMPONSKimberly-Clark Global Sales, Inc. · Tampon, menstrual, unscented126 reports
- U By Kotex KOTEX TAMPONSKimberly-Clark Global Sales, Inc. · Tampon, menstrual, unscented126 reports
- U by Kotex TamponKimberly-Clark Global Sales, Inc. · TAMPON, MENSTRUAL, UNSCENTED1 recall2 reports
- U by Kotex TamponKimberly-Clark Global Sales, Inc. · TAMPON, MENSTRUAL, UNSCENTED1 recall1 report
- TampaxProcter & Gamble Manufacturing Company, The · TAMPON, MENSTRUAL, UNSCENTED1 recall0 reports
- TampaxProcter & Gamble Manufacturing Company, The · TAMPON, MENSTRUAL, UNSCENTED1 recall0 reports
- U by Kotex TamponKimberly-Clark Global Sales, Inc. · TAMPON, MENSTRUAL, UNSCENTED1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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