Playtex 09923Recalls & reported problems
Edgewell Personal Care Brands, LLC · SPORT 36CT UNSCENT SUPER 4/3 $5 Reward · Class 2
- Adverse event reports
- 6
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00078300099239), received between Aug 5, 2016 and Aug 26, 2026 — classified as 1 death, 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility3
- Difficult to Remove2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Toxic Shock Syndrome4
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Break; Difficult to Remove
The consumer complains about the tampon string came unattached while she was wearing and had to visit to the emergencry room to make sure she had all of the tampon removed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452384 ↗MalfunctionDec 28, 2020Difficult to Remove; Manufacturing, Packaging or Shipping Problem
A FEMALE CONSUMER, OVER THE AGE OF 18 YEARS, REPORTED THAT SHE HAS BEEN USING PLAYTEX SPORT TAMPONS FOR YEARS AND HAS BEEN HAPPY WITH THEM. SHE REPORTED THAT SHE BOUGHT A BOX OF TAMPONS AND FOUND THAT WITH 4 OR 5 OF THEM THE STRINGS WERE NOT ATTACHED TO THE COTTON RATHER WERE STUCK TO THE APPLICATOR. SHE STATED THAT SHE THREW THEM AWAY AND USED ANOTHER ONE THAT LOOKED FINE. WHEN SHE WENT TO REMOVE THE TAMPON, THE STRING BROKE AND SHE WAS UNABLE TO REMOVE THE TAMPON ON HER OWN. ON THE SAME DAY SHE WENT TO URGENT CARE TO HAVE THE TAMPON REMOVED. NO FURTHER TREATMENT OR MEDICATION WAS PRESCRIBED AND NO FOLLOW UP WAS NEEDED. CONSUMER STATED THAT SHE WAS HEALING.
Patient problems: Insufficient Information
MAUDE report 11078099 ↗DeathMay 2, 2019Adverse Event Without Identified Device or Use Problem
ON 11-MAR-2020 AN EDGEWELL COLLEAGUE RECEIVED A THREE-DAY OLD ONLINE NEWS ARTICLE AND AN OLDER STORY DATED 10-JUN-2019 CONCERNING A YOUNG WOMAN WHO DIED OF TSS IN (B)(6) 2017 AFTER USING PLAYTEX SPORT TAMPONS. AS PER THE ARTICLES, THE YOUNG WOMAN'S MOTHER STATED THAT HER DAUGHTER WAS A COLLEGE STUDENT WHO TRAVELLED HOME TO CELEBRATE HER (B)(6) BIRTHDAY WITH HER FAMILY. SHE STATED THAT ON (B)(6) 2017 HER DAUGHTER WAS NOT FEELING WELL WITH SYMPTOMS OF A STOMACH BUG AND AS THE NIGHT PROGRESSED HER SYMPTOMS WORSENED. SHE STATED THAT THE FOLLOWING NIGHT SHE WENT TO SLEEP STILL NOT FEELING WELL AND THEY HAD DECIDED THAT IF SHE WAS NOT FEELING BETTER BY THE MORNING THEY WOULD GO TO THE DOCTOR. ON THE MORNING OF (B)(6) 2017, WHEN SHE WENT TO WAKE UP HER DAUGHTER SHE WAS IN A SEMICONSCIOUS STATE AND COULD BARELY SPEAK. SHE CALLED 911 IMMEDIATELY AND BY THE TIME FIRST RESPONDERS ARRIVED SHE HAD SUFFERED A SEIZURE AND PASSED AWAY IN HER ARMS. THE CONSUMERS MOTHER STATED THAT THE DEATH CERTIFICATE CLEARLY STATED TOXIC SHOCK SYNDROME. EDGEWELL PERSONAL CARE HAS DETERMINED THAT THIS WAS THE SAME CASE THAT WAS INITIALLY REPORTED TO EDGEWELL BY THE FDA ON 26-APR-2019. TWO ATTEMPTS TO CONTACT THE Y
Patient problems: Toxic Shock Syndrome
MAUDE report 8575863 ↗InjuryMar 5, 2019Patient-Device Incompatibility
A FEMALE CONSUMER REPORTED THAT HER DAUGHTER WAS A HEALTHY, 16-YEAR-OLD, ATHLETE WHO CAME DOWN WITH TOXIC SHOCK SYNDROME (TSS) WHILE USING PLAYTEX SPORT TAMPONS. SHE STATED THAT HER DAUGHTER STARTED HER MENSES IN THE SEVENTH GRADE, HAD A HEAVY BLOOD FLOW AND ALWAYS USED SUPER ABSORBENCY TAMPONS. SHE STATED THAT HER DAUGHTER HAD SLEPT OVERNIGHT WITH THE TAMPON AND THE TAMPON WAS PROBABLY INSERTED FOR 9-10 HOURS. ON (B)(6) 2019 HER DAUGHTER WAS NOT FEELING WELL, HAD A FEVER OF 102, SYMPTOMS OF SWEATING, CHILLS, BODY ACHES AND LIGHTHEADEDNESS. ADVIL AND TYLENOL WERE TAKEN FOR THE SYMPTOMS. ON (B)(6) 2019 SHE HAD A FEVER OF 101.7, A BACKACHE, AN ITCHY RASH FROM HEAD TO TOE AND LEFT SIDED WEAKNESS. SHE TOOK HER TO THE PEDIATRICIAN'S OFFICE WHERE HER BLOOD PRESSURE WAS 80/50 AND HEART RATE WAS 120. THE PEDIATRICIAN ADVISED HER TO TAKE HER DAUGHTER TO THE EMERGENCY ROOM (ER). IN THE ER, BLOOD AND VAGINAL CULTURES WERE TAKEN AND INTRAVENOUS THERAPY OF ANTIBIOTICS; CLINDAMYCIN, VANCOMYCIN AND CEFTRIAXONE WERE STARTED. SHE WAS TRANSFERRED TO ANOTHER HOSPITAL'S PEDIATRIC INTENSIVE CARE UNIT WHERE NOREPINEPHRINE WAS ADMINISTERED DUE TO HER LOW BLOOD PRESSURE AND AN ARTERIAL LINE WAS INSERTED.
Patient problems: Toxic Shock Syndrome
MAUDE report 8391103 ↗InjuryJun 14, 2017Patient-Device Incompatibility; Patient-Device Incompatibility
MOTHER REPORTS HER (B)(6)-YEAR OLD DAUGHTER WAS DIAGNOSED WITH TSS ON (B)(6) 2016. DAUGHTER DEVELOPED SYMPTOMS OF HEADACHE, NAUSEA, VOMITING, DIARRHEA, SORE THROAT, TEMPERATURE OF 104, DELUSIONS AND DIZZINESS. MOTHER CONTACTED HER DAUGHTER'S PEDIATRICIAN BUT HE WAS UNABLE TO SEE HER SO SHE SOUGHT MEDICAL ATTENTION IN THE ER AT (B)(6), THEN HER DAUGHTER WAS AIR LIFTED TO (B)(6). BLOOD WORK WAS PERFORMED AND A DIAGNOSIS OF TSS WAS MADE. SHE REPORTS HER DAUGHTER'S KIDNEYS AND LIVER SHUT DOWN AND THE SKIN ON THE SOLES OF HER FEET AND PALMS WERE LOST. SHE STATES HER DAUGHTER WAS HOSPITALIZED FOR 10 DAYS DURING WHICH TIME SHE RECEIVED FOUR DIFFERENT TYPES OF IV ANTIBIOTICS INCLUDING VANCOMYCIN AND CLINDAMYCIN. DAUGHTER WAS DISCHARGED ON (B)(6)2016 AND MOTHER REPORTS HER DAUGHTER IS STILL A LITTLE WEAK BUT HAS OTHERWISE RECOVERED.
Patient problems: Toxic Shock Syndrome
MAUDE report 6641062 ↗InjuryAug 5, 2016Patient-Device Incompatibility; Patient-Device Incompatibility
(B)(6) REPORTED A CASE OF MENSTRUAL TSS ASSOCIATED WITH THE USE OF PLAYTEX SPORT SUPER TAMPONS. THE REPORTER STATED THAT THE DATE OF ONSET WAS (B)(6). THE PATIENT HAD SYMPTOMS OF FEVER, HYPOTENSION, RASH, VOMITING, DIARRHEA, SORE THROAT AND CARDIAC ARRYTHMIA AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) WHERE SHE WAS DIAGNOSED WITH TSS.
Patient problems: Toxic Shock Syndrome
MAUDE report 5850807 ↗
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
- Daye FG-TMP-MM-IB18180000Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 reports
- Daye FG-TMP-RET09000900Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 reports
- Daye FG-TMP-MM-REF18180000Tampon Innovations Ltd Ood · Tampon, Menstrual, Unscented1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.