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

Lot Number	16350W
Health Effect - Clinical Code	Toxic Shock Syndrome (2108)
Date of Event	03/26/2017
Type of Reportable Event	Death
Event or Problem Description
Edgewell received a verbal report from the fda on 26-apr-2019 that they received a report in the beginning of (b)(6) 2019 of an alleged toxic shock syndrome death from (b)(6) 2017.An image of playtex super unscented tampons package and date code were emailed to edgewell.
Event or Problem Description
On 11-mar-2020 an edgewell colleague received a three-day old online news article and an older story dated 10-jun-2019 concerning a young woman who died of tss in (b)(6) 2017 after using playtex sport tampons.As per the articles, the young woman's mother stated that her daughter was a college student who travelled home to celebrate her (b)(6) birthday with her family.She stated that on (b)(6) 2017 her daughter was not feeling well with symptoms of a stomach bug and as the night progressed her symptoms worsened.She stated that the following night she went to sleep still not feeling well and they had decided that if she was not feeling better by the morning they would go to the doctor.On the morning of (b)(6) 2017, when she went to wake up her daughter she was in a semiconscious state and could barely speak.She called 911 immediately and by the time first responders arrived she had suffered a seizure and passed away in her arms.The consumers mother stated that the death certificate clearly stated toxic shock syndrome.Edgewell personal care has determined that this was the same case that was initially reported to edgewell by the fda on 26-apr-2019.Two attempts to contact the young woman's mother via the email address provided in the article have been made with no response as of this time.
Event or Problem Description
On (b)(6) 2020 an edgewell colleague received a three-day old online news article and an older story dated (b)(6) 2019 concerning a young woman who died of tss in (b)(6) 2017 after using playtex sport tampons.As per the articles, the young woman's mother stated that her daughter was a college student who travelled home to celebrate her (b)(6) birthday with her family.She stated that on (b)(6) 2017 her daughter was not feeling well with symptoms of a stomach bug and as the night progressed her symptoms worsened.She stated that the following night she went to sleep still not feeling well and they had decided that if she was not feeling better by the morning they would go to the doctor.On the morning of (b)(6) 2017, when she went to wake up her daughter she was in a semiconscious state and could barely speak.She called 911 immediately and by the time first responders arrived she had suffered a seizure and passed away in her arms.The consumers mother stated that the death certificate clearly stated toxic shock syndrome.Edgewell personal care has determined that this was the same case that was initially reported to edgewell by the fda on 26-apr-2019.Two attempts to contact the young woman's mother via the email address provided in the article have been made with no response as of this time.Links to the online articles have been included in an attachment.Additional information received from the consumers mother on (b)(6) 2020 included that on the night before her daughters (b)(6) birthday she complained of nausea and the next day experienced vomiting, diarrhea and fever.On (b)(6) 2017 an ambulance was called but she passed away before the paramedics arrived.She was declared at the hospital and the cause of death was listed as tss.The product information was confirmed.

• Brand Name: PLAYTEX SPORT TAMPONS, 36CT SUPER UNSCENTED
• Common Device Name: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PLAYTEX MANUFACTURING INC.; 804 walker road; dover, de DE 19904
• MDR Report Key: 8575863
• Report Number: 2515444-2019-00004
• Device Sequence Number: 11221723
• Product Code: HEB
• UDI-Device Identifier: 00078300099239
• UDI-Public: 078300099239
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2020

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
• Device Lot Number: 16350W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 03/11/2020; 03/11/2020
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 04/09/2020; 07/09/2020
• 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: Death
• Patient Age: 19 YR