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

Lot Number 13330W

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Toxic Shock Syndrome (2108); Chills (2191); Anxiety (2328); Confusion/ Disorientation (2553)

Event Date 01/21/2014

Event Type  Injury  

Event Description

Mother of pt reported her (b)(6) daughter was diagnosed with toxic shock syndrome.On (b)(6) 2014, daughter developed chills, anxiousness, disorientation and a fever of 104 degrees.She was taken to a medical center by ambulance and diagnosed with tss.She was hospitalized until (b)(6) 2014.

• Brand Name: SPORT TAMPONS SUPER UNSCENTED
• Type of Device: MENSTRUAL TAMPON, UNSCENTED
• Manufacturer (Section D): PLAYTEX MANUFACTURING INC.; dover DE
• Manufacturer Contact: jennifer martin rempe ; 6 research dr.; shelton, CT 06484
• MDR Report Key: 3676757
• MDR Text Key: 4243894
• Report Number: 2515444-2014-00003
• Device Sequence Number: 1
• Product Code: HIL
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 13330W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 21 YR