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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Cellulitis (1768)

Event Date 05/01/2018

Event Type  Injury  

Event 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
• Type of Device: A170448
• Manufacturer (Section D): PLAYTEX MANUFACTURING, INC.; 804 walker road; dover DE 19904
• Manufacturer (Section G): PLAYTEX MANUFACTURING, INC.; 804 walker drive; dover DE 19904
• Manufacturer Contact: janet gonzalez ; 75 commerce drive; allendale, NJ 07401 ; 2017858047
• MDR Report Key: 8115766
• MDR Text Key: 128860665
• Report Number: 2515444-2018-00004
• Device Sequence Number: 1
• Product Code: HHD
• UDI-Device Identifier: 00078300070016
• UDI-Public: 078300070016
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 43 YR