MAUDE Adverse Event Report: PLAYTEX MANUFACTURING, INC. PLAYTEX GENTLE GLIDE 360O UNSCENTED SUPER PLUS 36 CT; PAD, MENSTRUAL, UNSCENTED

Model Number	078300098515
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Toxic Shock Syndrome (2108)
Date of Event	12/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There have been no product design or material changes attributable to the complaint.Manufacturing processes were executed per specifications and procedures.No documented incident with regards to related process deviations.All in-process checks and laboratory testing yielded acceptable results.
Event or Problem Description
Patient's mother called to report that at 3 o'clock in the morning of (b)(6) 2016, her daughter had symptoms of vomiting, diarrhea, fever and muscle pain.On (b)(6) 2016 she sought medical attention for her daughter at an urgent care center and then went to a hospital where her daughter was admitted.Vital signs were (b)(6) and her daughter was dehydrated.The mother reported that her daughter was treated with iv therapy, antibiotics of ancef and clindamycin and dilaudid for muscle pain.Her vital signs became stable and she was discharged on (b)(6) 2017 with a midline iv catheter for iv antibiotic therapy for 10 days.A diagnosis of tss was confirmed on (b)(6) 2017.The mother stated that her daughter was previously diagnosed with tss and hospitalized for three days in (b)(6) 2016.At that time her daughter had sudden symptoms of vomiting, diarrhea, fever and muscle pain.Blood work was performed, and her daughter was treated with iv therapy, antibiotics and dilaudid for muscle pain.She confirmed that her daughter continued to use tampons after the (b)(6) tss diagnosis.

• Brand Name: PLAYTEX GENTLE GLIDE 360O UNSCENTED SUPER PLUS 36 CT
• Common Device Name: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PLAYTEX MANUFACTURING, INC.; 805 walker rd; dover DE 19904
• MDR Report Key: 6283059
• Report Number: 2515444-2017-00001
• Device Sequence Number: 853133
• Product Code: HEB
• UDI-Device Identifier: 00078300098515
• UDI-Public: 078300098515
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/27/2017

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: 078300098515
• Device Lot Number: 16119BA
• Was Device Available for Evaluation?: No
• Device Age: 8 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2017
• Initial Report FDA Received Date: 01/27/2017
• 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
• Patient Age: 17 YR