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

Model Number FIT FLEX MAX WOMEN S/M

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Urinary Tract Infection (2120)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) and quality records were reviewed.These documents demonstrate that procedures were correctly followed.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 wife reported that in (b)(6) 2017 her husband experienced a bladder uti that required hospitalization for a week and a half.He was using either depend fit flex male or women product.Consumer's wife reported that the incontinence product was re-used on her husband.This report is for the fit flex max women.Mdr 2184163-2018-00003 has been submitted for the fit flex male product.He was prescribed antibiotics.His uti was resolved.Consumer's wife reported she was satisfied, no further follow ups are tasked.

• Brand Name: DEPEND
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION COLD SPRINGS; 1050 cold spring rd.; neenah WI 54956
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION COLD SPRINGS; 1050 cold spring rd.; neenah WI 54956
• Manufacturer Contact: marian vargas ; 2100 winchester rd; neenah, WI 54956 ; 9207215889
• MDR Report Key: 7751590
• MDR Text Key: 116060225
• Report Number: 2184163-2018-00002
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/06/2018

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: Lay User/Patient
• Device Model Number: FIT FLEX MAX WOMEN S/M
• Device Lot Number: LF714214X1244
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR