MAUDE Adverse Event Report: PLAYTEX MANUFACTURING, INC. PLAYTEX SPORT UNSCENTED TAMPONS, SUPER PLUS, 18 CT; MENSTRUAL TAMPON

Model Number X08135C0

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Toxic Shock Syndrome (2108)

Event Date 12/31/2015

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016, (b)(6) provided date codes and product descriptions for the event reported as mw5059966.This report describes the second product associated with the event.

Event Description

Fda contacted edgewell personal care on (b)(6) 2016, to inform edgewell that the agency has received four reports (mw5059966, mw5059967, mw5059968 and mw5060650) concerning adverse events involving playtex sport tampons.The reports indicate that four young women have been hospitalized at a single hospital since the beginning of the year with patient problem 2108: toxic shock syndrome.

• Brand Name: PLAYTEX SPORT UNSCENTED TAMPONS, SUPER PLUS, 18 CT
• Type of Device: MENSTRUAL TAMPON
• Manufacturer (Section D): PLAYTEX MANUFACTURING, INC.; 805 walker rd; dover DE 19904
• Manufacturer (Section G): PLAYTEX MANUFACTURING, INC.; 805 walker rd; dover DE 19904
• Manufacturer Contact: gale lydic ; 185 saulsbury rd; dover, DE 19904 ; 3026786429
• MDR Report Key: 5831565
• MDR Text Key: 50715752
• Report Number: 0002515444-2016-00008
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00078300081357
• UDI-Public: 078300081357
• 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: health professional
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: X08135C0
• Device Lot Number: 15196AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 1 YR
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other