PLAYTEX SPORT TAMPONS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-03-22 for PLAYTEX SPORT TAMPONS manufactured by Playtex Manufacturing Inc..

Event Text Entries

[103265354] Consumer (b)(6) reported via direct message to playtex on social media that she was hospitlaized for tss after using playex sport tampons when she was (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2515444-2018-00001
• MDR Report Key: 7363724
• Report Source: CONSUMER
• Date Received: 2018-03-22
• Date of Report: 2018-03-22
• Date Facility Aware: 2018-03-12
• Date Mfgr Received: 2018-03-12
• Date Added to Maude: 2018-03-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. KATHLEEN EDGAR
• Manufacturer Street: 75 COMMERCE DRIVE.
• Manufacturer City: ALLENDALE NJ 07401
• Manufacturer Country: US
• Manufacturer Postal: 07401
• Manufacturer Phone: 2017858070
• Manufacturer G1: PLAYTEX MANUFACTURING INC.
• Manufacturer Street: 804 WALKER DRIVE
• Manufacturer City: DOVER DE 19904
• Manufacturer Country: US
• Manufacturer Postal Code: 19904
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PLAYTEX SPORT TAMPONS
• Generic Name: MENSTRUAL TAMPON
• Product Code: HIL
• Date Received: 2018-03-22
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PLAYTEX MANUFACTURING INC.
• Manufacturer Address: 804 WALKER ROAD DOVER DE 19904 US 19904

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening	2018-03-22