MAUDE Adverse Event Report: PLAYTEX MANUFACTURING, INC. PLAYTEX SPORT MULTIPACK TAMPON, UNKNOWN; MENSTRUAL TAMPON

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxic Shock Syndrome (2108)

Event Date 12/26/2015

Event Type  Injury  

Event Description

Fda contacted edgewell personal care on march 9, 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 (b)(4).

Manufacturer Narrative

Playtex is correcting its mdr report after further investigation.Because playtex has no information whether the product used was scented or unscented we are re-submitting this report to indicate sport multipack unknown.

• Brand Name: PLAYTEX SPORT MULTIPACK TAMPON, UNKNOWN
• 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: 5836395
• MDR Text Key: 160393055
• Report Number: 2515444-2016-00002
• Device Sequence Number: 1
• Product Code: HEB
• 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,other
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/28/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 1 YR
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 08/01/2016
• Supplement Dates Manufacturer Received: 03/09/2016
• Supplement Dates FDA Received: 08/01/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other