MAUDE Adverse Event Report: PLAYTEX MANUFACTURING INC. PLAYTEX SPORT TAMPONS, SUPER UNSCENTED 36 CT; MENSTRUAL TAMPON

Model Number X09923J0

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Toxic Shock Syndrome (2108)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

Mother provided upcs for super and super plus absorbencies; she is unsure which product her daughter was using at the time.The model number, upc and lot codes for the super absorbency have been provided in this report, and are: model: x09923j0, upc: (b)(4), lot code: 16165w.The upc and lot codes for the super plus absorbency are: model: x08136c0, upc: (b)(4), lot code: 16168ac.

Event Description

Mother reports her (b)(6)-year old daughter was diagnosed with tss on (b)(6) 2016.Daughter developed symptoms of headache, nausea, vomiting, diarrhea, sore throat, temperature of 104, delusions and dizziness.Mother contacted her daughter's pediatrician but he was unable to see her so she sought medical attention in the er at (b)(6), then her daughter was air lifted to (b)(6).Blood work was performed and a diagnosis of tss was made.She reports her daughter's kidneys and liver shut down and the skin on the soles of her feet and palms were lost.She states her daughter was hospitalized for 10 days during which time she received four different types of iv antibiotics including vancomycin and clindamycin.Daughter was discharged on (b)(6)2016 and mother reports her daughter is still a little weak but has otherwise recovered.

• Brand Name: PLAYTEX SPORT TAMPONS, SUPER UNSCENTED 36 CT
• 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 road; dover DE 19904
• Manufacturer Contact: vicki heath ; 804 walker road; dover, DE 19904 ; 3026786668
• MDR Report Key: 6641062
• MDR Text Key: 77605291
• Report Number: 2515444-2017-00004
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00078300099239
• UDI-Public: 078300099239
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/14/2017

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: X09923J0
• Device Lot Number: 16165W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2016
• 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; Life Threatening
• Patient Age: 12 YR