Playtex 09851Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00078300098515), received between Jan 27, 2017 and Jan 27, 2017 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT'S MOTHER CALLED TO REPORT THAT AT 3 O'CLOCK IN THE MORNING OF (B)(6) 2016, HER DAUGHTER HAD SYMPTOMS OF VOMITING, DIARRHEA, FEVER AND MUSCLE PAIN. ON (B)(6) 2016 SHE SOUGHT MEDICAL ATTENTION FOR HER DAUGHTER AT AN URGENT CARE CENTER AND THEN WENT TO A HOSPITAL WHERE HER DAUGHTER WAS ADMITTED. VITAL SIGNS WERE (B)(6) AND HER DAUGHTER WAS DEHYDRATED. THE MOTHER REPORTED THAT HER DAUGHTER WAS TREATED WITH IV THERAPY, ANTIBIOTICS OF ANCEF AND CLINDAMYCIN AND DILAUDID FOR MUSCLE PAIN. HER VITAL SIGNS BECAME STABLE AND SHE WAS DISCHARGED ON (B)(6) 2017 WITH A MIDLINE IV CATHETER FOR IV ANTIBIOTIC THERAPY FOR 10 DAYS. A DIAGNOSIS OF TSS WAS CONFIRMED ON (B)(6) 2017. THE MOTHER STATED THAT HER DAUGHTER WAS PREVIOUSLY DIAGNOSED WITH TSS AND HOSPITALIZED FOR THREE DAYS IN (B)(6) 2016. AT THAT TIME HER DAUGHTER HAD SUDDEN SYMPTOMS OF VOMITING, DIARRHEA, FEVER AND MUSCLE PAIN. BLOOD WORK WAS PERFORMED, AND HER DAUGHTER WAS TREATED WITH IV THERAPY, ANTIBIOTICS AND DILAUDID FOR MUSCLE PAIN. SHE CONFIRMED THAT HER DAUGHTER CONTINUED TO USE TAMPONS AFTER THE (B)(6) TSS DIAGNOSIS.

  Patient problems: Toxic Shock Syndrome

  MAUDE report 6283059 ↗