MAUDE Adverse Event Report: PLAYTEX MANUFACTURING, INC. CARE FREE ORIGINAL UNSCENTED LINERS 49CT; A170448

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A (b)(6) year old female consumer reported that beginning in (b)(6) 2018, each time she would have her period she would notice an irritation in her perineal area that was very painful.She stated that she started changing things but only used panty liners during menstruation, had used them for years and did not change brands.She went to her doctor and was prescribed antibiotics and stated that nothing would help.She purchased an anti-itch cream to treat the reactions that she stated occurred four times.Consumer stated that she went to her physician's office twice before being admitted to the hospital on (b)(6) 2018.She reported that she was tested for sexually transmitted diseases (stds) and a complete blood count (cbc) was done and all results were negative.She stated that she was then diagnosed with a cellulitis skin infection from the open sores.During the hospitalization she was treated with numerous antibiotics and steroids: vancomycin, ketoconazole, clotrimazole, amitriptyline, triamcinolone, doxycycline and hydroxyzine for itching.The consumer reported that she was in the hospital for four nights and was discharged from the hospital over the memorial day holiday weekend (exact date not provided).The consumer reported that she was healing and a follow up visit was scheduled for (b)(6) 2018.

• Brand Name: CARE FREE ORIGINAL UNSCENTED LINERS 49CT
• Common Device Name: A170448
• Manufacturer (Section D): PLAYTEX MANUFACTURING, INC.; 804 walker road; dover DE 19904
• MDR Report Key: 8115766
• Report Number: 2515444-2018-00004
• Device Sequence Number: 1670485
• Product Code: HHD
• UDI-Device Identifier: 00078300070016
• UDI-Public: 078300070016
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 11/29/2018
• 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: 43 YR