MAUDE Adverse Event Report: PLAYTEX MANUFACTURING, INC. PLAYTEX SPORT FRESH BALANCE 32 CT MULTIPACK SCENTED REGULAR/SUPER; MENSTRUAL TAMPON

Model Number	078300002208
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Toxic Shock Syndrome (2108)
Date of Event	06/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the consumer has not returned the product for evaluation.A review of the device history record for the date code provided confirmed that the device meets specifications.
Event or Problem Description
Consumer reported that within an hour of using the product she developed a high fever, vomiting and diarrhea, but symptoms subsided upon removal of the product.She sought medical attention two days later but no treatment was prescribed.Consumer reports that "her doctor stated her symptoms were more than likely tss." consumer added she had symptoms of tss a few years ago but did not seek medical attention at that time.

• Brand Name: PLAYTEX SPORT FRESH BALANCE 32 CT MULTIPACK SCENTED REGULAR/SUPER
• Common Device Name: MENSTRUAL TAMPON
• Manufacturer (Section D): PLAYTEX MANUFACTURING, INC.; 805 walker rd; dover DE 19904
• MDR Report Key: 5831544
• Report Number: 0002515444-2016-00007
• Device Sequence Number: 251334
• Product Code: HIL
• UDI-Device Identifier: 00078300002208
• UDI-Public: 078300002208
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 078300002208
• Device Lot Number: 16035CA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2016
• Initial Report FDA Received Date: 07/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other