MAUDE Adverse Event Report: PLAYTEX MANUFACTURING, INC. PLAYTEX SPORT 36 CT MULTIPACK UNSCENTED TAMPONS (REGULAR & SUPER, 18/EA); MENSTRUAL TAMPON

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Toxic Shock Syndrome (2108)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

On thursday (b)(6) 2016, patient's mother called (b)(4) to report details on her daughter's tss event.She stated that on a sunday her daughter stated she was not feeling well.She was menstruating at the time, but the start date was unknown.She went to school on monday but that night she began vomiting.On tuesday the mother called a doctor who advised her to keep hydrated and see how she feels after 24 hours.By wednesday, her daughter had developed a fever, and the vomiting continued.The mother called the doctor again and was told to "give it more time." on thursday the daughter continued to vomit and began having diarrhea, and the mother called the doctor who told her to come in for an office visit that day.When the daughter showed her mother that a rash had begun to appear on her stomach, the mother called the doctor's office back to tell them this, and she was told take her daughter to the emergency room right away where she was diagnosed with tss.

Event Description

Fda contacted (b)(4) on march 9, 2016, to inform (b)(4) that the agency has received four reports (mw5059966, mw5059967, mw5059968 and mw5060650) concerning adverse events involving playtex sport tampons.The reports indicate that four young women have been hospitalized at a single hospital since the beginning of the year with patient problem 2108: toxic shock syndrome.

• Brand Name: PLAYTEX SPORT 36 CT MULTIPACK UNSCENTED TAMPONS (REGULAR & SUPER, 18/EA)
• 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: 5850803
• MDR Text Key: 51274094
• Report Number: 2515444-2016-00004
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 78300099338
• UDI-Public: 783000-99338
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/05/2016

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 1 YR
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 15 YR