MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION - COLD SPRINGS DEPEND, POISE; GARMENT, PROTECTIVE, FOR INCONTINENCE

Model Number LARGE/X-LARGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) and quality records were reviewed.These documents demonstrate that procedures were correctly followed.No other similar or related complaints for the reported lot were found.Complaints which are serious in nature are reviewed on a regular basis or for due cause to provide visibility and escalation.In addition, complaints are also monitored for trending on a monthly cadence.No further information is available at this time.

Event Description

Consumer's daughter stated that her mother is elderly and disabled and cannot afford enough depends to change them regularly and it is causing her to have constant urinary track infections (uti).In the past, her mother had been hospitalized several times for utis.For this recent occurrence incident, she was diagnosed with kidney and bladder infection, and was hospitalized for two days.During last wellness check ((b)(6) 2017), the consumer's daughter stated her mother's uti was resolved and was doing well.No further information is available.

Manufacturer Narrative

New information: this is a follow up to submit a correction to the initial report for the removal of product problem and addition of adverse event.This was an adverse event since there was no product defect/malfunction.

Event Description

This is a follow-up to submit a correction to the initial report for the removal of product problem from b1 and addition of adverse event.This was an adverse event since there was no product defect/malfunction.

• Brand Name: DEPEND, POISE
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION - COLD SPRINGS; 1050 cold spring road; neenah WI 54956
• MDR Report Key: 7133478
• MDR Text Key: 95373706
• Report Number: 3003701733-2017-00024
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LARGE/X-LARGE
• Device Lot Number: LF714319X2158
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR