MAUDE Adverse Event Report: P AND G ALWAYS PADS AND PANTYLINER

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Incontinence (1928); Skin Discoloration (2074)

Event Date 10/20/2015

Event Type  Injury  

Event Description

Initially noted flat black moles along panty line bilateral.Largest approximately 2-3 cm in diameter located on the left, and the one on the right was approximately 1-2 with dark discoloration of the inner labia in multiple areas.Followed up with ob/gyn (b)(6) 2015, initial biopsy obtained resulted (b)(6) 2016 squamous cell carcinoma (vulva cancer).At age (b)(6), underwent surgery (wide resection modified vulvectomy) on (b)(6) 2016.Of note, no pre-existing factors noted i.E.No (b)(6), no genital warts, no multiple sexual partners.The only things constant in past 13 years is the use of always pads for initially menses, then urine leakage daily.The positioning of the cancerous lesions were along the area that the pad would come in contact with, the external labia.

• Brand Name: ALWAYS PADS AND PANTYLINER
• Type of Device: ALWAYS PADS AND PANTYLINER
• Manufacturer (Section D): P AND G
• MDR Report Key: 5570241
• MDR Text Key: 42533275
• Report Number: MW5061621
• Device Sequence Number: 1
• Product Code: HHD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/07/2016

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 93