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

Model Number	X09923J0
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Toxic Shock Syndrome (2108)
Date of Event	08/23/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: MENSTRUAL TAMPON
• Manufacturer (Section D): PLAYTEX MANUFACTURING INC.; 804 walker road; dover DE 19904
• MDR Report Key: 6641062
• Report Number: 2515444-2017-00004
• Device Sequence Number: 926167
• Product Code: HEB
• UDI-Device Identifier: 00078300099239
• UDI-Public: 078300099239
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K132819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: X09923J0
• Device Lot Number: 16165W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 12 YR