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

Device Problem Compatibility Problem (2960)

Patient Problems Toxic Shock Syndrome (2108); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

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).

• Brand Name: PLAYTEX SPORT TAMPONS
• Type of Device: MENSTRUAL TAMPON
• Manufacturer (Section D): PLAYTEX MANUFACTURING INC.; 804 walker road; dover DE 19904
• Manufacturer (Section G): PLAYTEX MANUFACTURING INC.; 804 walker drive; dover DE 19904
• Manufacturer Contact: kathleen edgar ; 75 commerce drive.; allendale, NJ 07401 ; 2017858070
• MDR Report Key: 7363724
• MDR Text Key: 103265354
• Report Number: 2515444-2018-00001
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): N
• PMA/PMN Number: K132819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2018
• Date Manufacturer Received: 03/12/2018
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 15 YR