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

Model Number 078300002208

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Toxic Shock Syndrome (2108)

Event Date 06/04/2016

Event Type  Injury  

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 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
• Type of Device: MENSTRUAL TAMPON
• Manufacturer (Section D): PLAYTEX MANUFACTURING, INC.; 805 walker rd; dover DE 19904
• Manufacturer (Section G): PLAYTEX MANUFACTURING, INC.; 805 walker rd; dover DE 19904
• Manufacturer Contact: gale lydic ; 185 saulsbury rd; dover, DE 19904 ; 3026786429
• MDR Report Key: 5831544
• MDR Text Key: 50715118
• Report Number: 0002515444-2016-00007
• Device Sequence Number: 1
• Product Code: HIL
• UDI-Device Identifier: 00078300002208
• UDI-Public: 078300002208
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 078300002208
• Device Lot Number: 16035CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2016
• Date Device Manufactured: 02/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other