MAUDE Adverse Event Report: KIMBERLY CLARK CORP. DEPEND SILHOUETTE; GARMENT, PROTECTIVE, FOR INCONTINENCE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abrasion (1689); Swelling (2091)

Event Date 07/31/2017

Event Type  Injury  

Event Description

I used a depend silhouette diaper for the first time in my (b)(6) daughter who is paraplegic.This diaper has a super absorbing band, and it was merchandised as a night adult incontinence diaper.The next morning her genital area was totally swollen and shows an abrasion in the left groin area.A few days later, her skin broke in the abrasion area and required many months of medical treatment due to the fact that it formed an open injury.Product type: otc.Frequency: at bedtime.How was it taken or used? topical.Dates of use: (b)(6) 2017 - (b)(6) 2017.Reason for use: urinary incontinence.

• Brand Name: DEPEND SILHOUETTE
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY CLARK CORP.
• MDR Report Key: 8597126
• MDR Text Key: 144690363
• Report Number: MW5086512
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 70