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

Model Number X09933JO

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Toxic Shock Syndrome (2108)

Event Date 02/21/2016

Event Type  Injury  

Manufacturer Narrative

On april 27, the (b)(6) health district provided to edgewell the upc for the suspect product.

Event Description

The mother reported that on (b)(6) 2016, during a cruise, her daughter began to experience nausea, lightheadedness, vomiting and diarrhea.She stated these symptoms occurred before her daughter used a tampax cardboard tampon for the first time.The symptoms worsened and she went to the ship doctor who prescribed "(b)(6) worth of medicine," including an antispasmodic called buspocan as well as other things.The next day she was well enough to go snorkeling and swimming.When she flew home, she forgot her medicine in her luggage, so it was not clear how many doses she missed.On (b)(6) 2016, the daughter used what her mother described as a playtex sport slender.[playtex does not make a tampon with this description.] the symptoms she had on the cruise began again, except with no vomiting or diarrhea.The following morning she was brought to the children's hospital and diagnosed with tss.

Manufacturer Narrative

On march 10, the (b)(6) department of health provided images of the suspect product in this case.On (b)(6), the patient's mother contacted edgewell to provide additional facts in this case.She reported that her daughter has been using tampons since menstruation began 6 years earlier.On (b)(6) 2016, her daughter was on the end of her period and began to feel ill.The mother reports her daughter had vomiting, 102 of fever, 50/25 blood pressure, pulse 135.She also stated her daughter could not feel her feet and hands and her kidneys were shutting down.The mother brought her daughter to the er where she was diagnosed with tss.The mother advised that her daughter had used a super tampon at the start of the day but the tampon was removed 18 hours prior to their going to the hospital.

Event Description

Fda contacted edgewell on march 9, 2016, to inform edgewell 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 (b)(4): toxic shock syndrome.This event was reported as mw5060650.Mw5060650 references upc # (b)(4), which represents playtex sport 36 ct multipack unscented (regular & super, 18/ea).Mw5060650 also states that the patient reports using a regular absorbency tampon from the multipack.

• Brand Name: PLAYTEX SPORT 36 CT MULTIPACK UNSCENTED (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: 5831554
• MDR Text Key: 50836134
• Report Number: 0002515444-2016-00006
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00078300026038
• UDI-Public: 078300026038
• 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,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: X09933JO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 1 YR
• Event Location: Home
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 17 YR