PLAYTEX TAMPONS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-13 for PLAYTEX TAMPONS manufactured by .

Event Text Entries

[3042651] Toxic shock syndrome after use of playtex tampons that were frequently changed due to heavy menstrual flow. Went to the emergency room with severe vomiting, diarrhea and fever. Was sent home and was told it was a stomach virus. The next morning she was lightheaded and passed out when trying to stand. Fever had risen to 104. 5 was taken back to emergency room where bp was 60s/30s. She developed a rash and could not urinate even after iv fluids and was having difficulty breathing. She was finally admitted to hospital and then transported to ach in little rock, arkansas where she arrived in critical condition. She was placed on a ventilator and medically induced coma for 9 days. Admission diagnosis: septic shock. Other diagnosis: hypercoagulability, electrolyte imbalances, respiratory failure, pancolitis, left pleural effusion, status post chest tube placement. Dates of use: (b)(6) 2009. Reason for use: menstrual cycle.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5027654
• MDR Report Key: 2837509
• Date Received: 2012-11-13
• Date of Report: 2012-11-13
• Date of Event: 2009-10-12
• Date Added to Maude: 2012-11-20
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PLAYTEX TAMPONS
• Generic Name: NONE
• Product Code: HIL
• Date Received: 2012-11-13
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention	2012-11-13