MAUDE Adverse Event Report: PLAYTEX MANUFACTURING INC. PLAYTEX SPORT TAMPONS, SUPER+ UNSCENTED 36CT.; TAMPON, MENSTRUAL, UNSCENTED

Health Effect - Clinical Code	Toxic Shock Syndrome (2108)
Date of Event	11/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A (b)(6) female consumer posted on social media that she used playtex sport tampons and on (b)(6) (unspecified year) she started to feel ill, vomited several times and took zofran that she had been prescribed a few months earlier after a surgery.She stated that she was taken to the hospital via ambulance after her parents felt that her responses to their questions did not make sense and the sclera of her "eyes was" red.She stated that she had no memory of the events.At the hospital her rectal temperature was 105.7 degrees and she underwent numerous tests including a spinal tap, a magnetic resonance imaging (mri), a cat scan, an ultrasound and dopplers.The following day she woke up in the intensive care unit (icu) and the doctor told her that she had toxic shock syndrome (tss), that the infection was aggressive, and had put her into kidney failure with her kidneys working at 30%.She was told that she had become septic and was treated with several antibiotics, fluids and medicine to increase her blood pressure.She stated that she was unable to move or feel her legs and that they were painful to the touch.She was transferred to another hospital for continued treatment and eventually released.
Event or Problem Description
A 23-year-old female consumer posted on social media that she used playtex sport tampons and on 11/24 (unspecified year) she started to feel ill, vomited several times and took zofran that she had been prescribed a few months earlier after a surgery.She stated that she was taken to the hospital via ambulance after her parents felt that her responses to their questions did not make sense and the sclera of her eyes was red.She stated that she had no memory of the events.At the hospital her rectal temperature was 105.7 degrees and she underwent numerous tests including a spinal tap, a magnetic resonance imaging (mri), a cat scan, an ultrasound and dopplers.The following day she woke up in the intensive care unit (icu) and the doctor told her that she had toxic shock syndrome (tss), that the infection was aggressive, and had put her into kidney failure with her kidneys working at 30%.She was told that she had become septic and was treated with several antibiotics, fluids and medicine to increase her blood pressure.She stated that she was unable to move or feel her legs and that they were painful to the touch.She was transferred to another hospital for continued treatment and eventually released.Additional information received on 02/15/2019: the consumer reported that she had a history of polycystic ovary syndrome (pcos) which prevented her from getting her period until she was 23 years old.The date of her first period was 05/2018.She stated that the event occurred on (b)(6) 2018 and she was hospitalized on (b)(6) 2018 for ten days.She stated that she still has the tampon box but did not want to return it.

• Brand Name: PLAYTEX SPORT TAMPONS, SUPER+ UNSCENTED 36CT.
• Common Device Name: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PLAYTEX MANUFACTURING INC.; 804 walker road; dover DE 19904
• MDR Report Key: 8281787
• Report Number: 2515444-2019-00001
• Device Sequence Number: 13988494
• Product Code: HEB
• UDI-Device Identifier: 00078300081364
• UDI-Public: 078300081364
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/04/2019
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 23 YR