Playtex 08135Recalls & reported problems
Edgewell Personal Care Brands, LLC · Playtex Sport 18CT Sup Plus Uns · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00078300081357), received between Jul 28, 2016 and Jul 28, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Toxic Shock Syndrome1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2016Patient-Device Incompatibility; Patient-Device Incompatibility
FDA CONTACTED EDGEWELL PERSONAL CARE ON (B)(6) 2016, TO INFORM EDGEWELL THAT THE AGENCY HAS RECEIVED FOUR REPORTS (MW5059966, MW5059967, MW5059968 AND MW5060650) CONCERNING ADVERSE EVENTS INVOLVING PLAYTEX SPORT TAMPONS. THE REPORTS INDICATE THAT FOUR YOUNG WOMEN HAVE BEEN HOSPITALIZED AT A SINGLE HOSPITAL SINCE THE BEGINNING OF THE YEAR WITH PATIENT PROBLEM 2108: TOXIC SHOCK SYNDROME.
Patient problems: Toxic Shock Syndrome
MAUDE report 5831565 ↗
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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