MAUDE Adverse Event Report: KIMBERLY CLARK CORP POISE PADS LONG LENGTH; GARMENT, PROTECTIVE FOR INCONTINENCE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 03/01/2016

Event Type  Injury  

Event Description

Have been using poise incontinence pads.Developed extremely itchy rash where pad touches - lower abdomen to above anus (long length pads).Thought at first it was a vaginal yeast infection, but i had no itching inside vagina; only externally.Intense itching.Finally stopped using pads.The next day, itching started decreasing.Looked it up on the internet.Complaints going back to 2014.Is this product over the counter? yes.

• Brand Name: POISE PADS LONG LENGTH
• Type of Device: GARMENT, PROTECTIVE FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY CLARK CORP
• MDR Report Key: 7705777
• MDR Text Key: 114745126
• Report Number: MW5078481
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• 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: 07/18/2018

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 67 YR