Playtex 08136Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00078300081364), received between Oct 10, 2018 and Jan 28, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2019Patient-Device Incompatibility

  A (B)(6) FEMALE CONSUMER POSTED ON SOCIAL MEDIA THAT SHE USED PLAYTEX SPORT TAMPONS AND ON (B)(6) (UNSPECIFIED YEAR) SHE STARTED TO FEEL ILL, VOMITED SEVERAL TIMES AND TOOK ZOFRAN THAT SHE HAD BEEN PRESCRIBED A FEW MONTHS EARLIER AFTER A SURGERY. SHE STATED THAT SHE WAS TAKEN TO THE HOSPITAL VIA AMBULANCE AFTER HER PARENTS FELT THAT HER RESPONSES TO THEIR QUESTIONS DID NOT MAKE SENSE AND THE SCLERA OF HER "EYES WAS" RED. SHE STATED THAT SHE HAD NO MEMORY OF THE EVENTS. AT THE HOSPITAL HER RECTAL TEMPERATURE WAS 105.7 DEGREES AND SHE UNDERWENT NUMEROUS TESTS INCLUDING A SPINAL TAP, A MAGNETIC RESONANCE IMAGING (MRI), A CAT SCAN, AN ULTRASOUND AND DOPPLERS. THE FOLLOWING DAY SHE WOKE UP IN THE INTENSIVE CARE UNIT (ICU) AND THE DOCTOR TOLD HER THAT SHE HAD TOXIC SHOCK SYNDROME (TSS), THAT THE INFECTION WAS AGGRESSIVE, AND HAD PUT HER INTO KIDNEY FAILURE WITH HER KIDNEYS WORKING AT 30%. SHE WAS TOLD THAT SHE HAD BECOME SEPTIC AND WAS TREATED WITH SEVERAL ANTIBIOTICS, FLUIDS AND MEDICINE TO INCREASE HER BLOOD PRESSURE. SHE STATED THAT SHE WAS UNABLE TO MOVE OR FEEL HER LEGS AND THAT THEY WERE PAINFUL TO THE TOUCH. SHE WAS TRANSFERRED TO ANOTHER HOSPITAL FOR CONTINUED TREATMENT AND EVENT

  Patient problems: Toxic Shock Syndrome

  MAUDE report 8281787 ↗
• InjuryOct 10, 2018Difficult to Remove

  THIS (B)(6) FEMALE CONSUMER REPORTED THAT SHE REMOVED A SUPER PLUS TAMPON WITH SOME DIFFICULTY AND LATER NOTICED THAT HER VAGINA WAS NOT RIGHT. CONSUMER DID NOT KNOW THE ACTUAL DATE BUT STATED THAT ABOUT SIX MONTHS BACK SHE WENT TO THE DOCTOR AND WAS DIAGNOSED WITH INTERIOR/EXTERIOR WALL VAGINAL PROLAPSE. THE CONSUMER STATED THAT TREATMENT WAS NOT PROVIDED BUT THAT SHE WAS TOLD THAT THEY CAN DO A NON-INVASIVE LASER PROCEDURE OR A SURGERY. THE CONSUMER STATED THAT SHE WAS NOT INTERESTED IN SURGERY BUT WOULD CONSIDER LASER TREATMENT. ON (B)(6) 2018 THE CONSUMER REPORTED THAT PRIOR TO SEEKING MEDICAL ATTENTION SHE HAD AND CURRENTLY HAS VAGINAL DISCOMFORT AND PAIN WITH INTERCOURSE. SHE STATED THAT THE VAGINAL DISCOMFORT HAS AFFECTED HER QUALITY OF LIFE AND THE PERSON THAT SHE IS BECAUSE IT HAS CAUSED HER PAIN DURING INTERCOURSE. THE CONSUMER STATED THAT SHE IS NOW LOOKING TO DO THE NON-INVASIVE PROCEDURE INVOLVING LASER AND NEEDS FINANCIAL HELP. ACCORDING TO THE MEDICAL RECORD RECEIVED FROM HER PHYSICIAN, THE CONSUMER WAS SEEN ON (B)(6) 2017 FOR ASSESSMENT OF DYSPAREUNIA AND PROLAPSE. HER MEDICAL HISTORY INCLUDED GRAVIDA 3 / PARA 3, THREE CESAREAN SECTIONS, NO ALLERGIES AND OCCASIONAL

  Patient problems: Patient Problem/Medical Problem; Prolapse

  MAUDE report 7952669 ↗