ALWAYS PADS AND PANTYLINER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-07 for ALWAYS PADS AND PANTYLINER manufactured by P And G.

Event Text Entries

[42533275] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5061621
MDR Report Key	5570241
Date Received	2016-04-07
Date of Report	2016-04-07
Date of Event	2015-10-20
Date Added to Maude	2016-04-12
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	PATIENT
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	0

Device Details

Brand Name	ALWAYS PADS AND PANTYLINER
Generic Name	ALWAYS PADS AND PANTYLINER
Product Code	HHD
Date Received	2016-04-07
Operator	LAY USER/PATIENT
Device Availability	N
Device Eval'ed by Mfgr	*
Device Sequence No	1
Device Event Key	0
Manufacturer	P AND G

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-04-07