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

Model Number 078300098515

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Toxic Shock Syndrome (2108)

Event Date 12/29/2016

Event Type  Injury  

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 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
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• 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: vicki heath ; 804 walker rd; dover, DE 19904 ; 3026786668
• MDR Report Key: 6283059
• MDR Text Key: 65954825
• Report Number: 2515444-2017-00001
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00078300098515
• UDI-Public: 078300098515
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 078300098515
• Device Lot Number: 16119BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 8 MO
• Initial Date Manufacturer Received: 01/02/2017
• Initial Date FDA Received: 01/27/2017
• Date Device Manufactured: 04/29/2016
• 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
• Patient Age: 17 YR