Playtex 09922Recalls & reported problems
Edgewell Personal Care Brands, LLC · SPORT 36CT REG UNSCENT 4/3 $5 Reward · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00078300099222), received between Sep 2, 2020 and Sep 24, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break3
- Difficult to Remove2
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Complaint, Ill-Defined1
- Discomfort1
- Foreign Body In Patient1
- Insufficient Information1
- Nausea1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Break
The consumer stated the tampon failed, and upon removal strings broke while product remained inserted. Urgent care visit required for removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884292 ↗InjuryAug 18, 2026Break; Difficult to Remove
Consumer mentions that the string broke when she went to remove the tampon. She had to visit Urgent care and get it removed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307357 ↗MalfunctionApr 14, 2026Break
PROBLEM REPORTED : THE REPORTER STATED THAT WHEN THEIR 17 YR OLD DAUGHTER WAS REMOVING A TAMPON AND THE STRING CAME OUT WITHOUT THE TAMPON. WHEN SHE TRIED TO GET THE TAMPON, SHE COULDN'T. AFTER 2 HOURS OF TRYING, WE WENT TO THE EMRGENCY ROOM. THE DOCTOR SAID THAT THE TAMPON HAD MIGRATED AS FAR UP AS IT POSSIBLY COULD GO TO THE CERVIX. NEEDLESS TO SAY, REMOVING THIS WITH FORCEPS WAS QUITE TRAUMATIC FOR A 17 YEAR OLD GIRL WHO HAD NOT YET HAD HER FIRST OB/GYN EXAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879778 ↗MalfunctionDec 29, 2020Material Separation
A FEMALE CONSUMER, OVER THE AGE OF 18 YEARS, REPORTED THAT SHE INSERTED A TAMPON BEFORE GOING ON A LONG BICYCLE RIDE. WHEN SHE RETURNED HOME AND TRIED TO CHANGE THE TAMPON, THE STRING PULLED COMPLETELY OUT OF THE TAMPON WITH NO BREAKAGE. SHE STATED THAT SHE WAS UNABLE TO REMOVE THE TAMPON AND WENT TO URGENT CARE TO HAVE THE TAMPON REMOVED ON THE SAME DAY. THE URGENT CARE PHYSICIANS WERE UNABLE TO REMOVE THE TAMPON AND SHE WAS ADVISED TO GO TO THE EMERGENCY ROOM. IN THE EMERGENCY ROOM, THE PHYSICIAN USED TOPICAL LIDOCAINE TO NUMB THE AREA AND USED A TOOL TO DISLODGE THE TAMPON. SHE WAS ADVISED TO FOLLOW UP WITH HER GYNECOLOGIST IF SHE HAD ANY COMPLICATIONS. SHE STATED THAT SHE HAD SOME DISCOMFORT BUT WAS HEALING.
Patient problems: Discomfort; Foreign Body In Patient
MAUDE report 11090088 ↗MalfunctionOct 14, 2020Difficult to Remove; Difficult to Remove
CONSUMER REPORTED THAT SHE WAS AT THE END OF HER MENSTRUAL CYCLE WHEN SHE INSERTED A TAMPON BECAUSE SHE WAS SPOTTING. CONSUMER STATED THAT SHE WENT TO REMOVE THE TAMPON THAT NIGHT, DID NOT FIND THE STRING AND THOUGHT SHE HAD FORGOTTEN THAT SHE ALREADY REMOVED IT. CONSUMER REPORTED THAT IN THE FOLLOWING DAYS SHE CONTINUED TO EXPERIENCE SPOTTING AND HAD A FOUL SMELL. ON (B)(6) 2020, FOUR DAYS AFTER THE TAMPON WAS INSERTED, SHE WOKE UP FEELING VERY ILL WITH NAUSEA AND COLD-LIKE SYMPTOMS. SHE SELF-CHECKED INTERNALLY WHILE IN SHOWER AS SHE WAS CONCERNED SOME OF THE TAMPON MAY HAVE REMAINED INSIDE OF HER, WHEN SHE DISCOVERED THE TAMPON WAS STILL INSERTED. SHE WAS UNABLE TO REMOVE THE TAMPON AND RUSHED TO THE EMERGENCY ROOM FEARING THAT SHE WAS SUFFERING FROM TOXIC SHOCK SYNDROME (TSS). THE TAMPON WAS REMOVED BY MEDICAL STAFF AND IT WAS DISCOVERED THAT THERE WAS NO STRING ATTACHED TO THE TAMPON. CONSUMER STATED THAT BLOOD WORK (UNSPECIFIED) DONE IN THE ER DID NOT SHOW ANY INFECTION OR TSS. NO MEDICATIONS WERE PRESCRIBED AND NO FOLLOW APPOINTMENT WAS REQUIRED. CONSUMER STATED THAT SHE DID NOT NOTICE THAT THE TAMPON DID NOT HAVE A STRING PRIOR TO INSERTION. CONSUMER REPORTED THAT SHE HAS RE
Patient problems: Complaint, Ill-Defined; Nausea
MAUDE report 10677340 ↗MalfunctionSep 2, 2020Detachment of Device or Device Component
A FEMALE CONSUMER REPORTED THAT WHEN SHE TRIED TO REMOVE THE TAMPON THE STRING CAME OUT AND THE TAMPON DID NOT. CONSUMER STATED THAT SHE HAD TO GO TO URGENT CARE ON (B)(6) 2020 TO HAVE THE TAMPON REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 10484181 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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