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

Model Number FIT FLEX MALE S/M

Device Problem Device Appears to Trigger Rejection (1524)

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

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and records can be performed.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 male.Mdr 2184163-2018-00002 has been submitted for the fit flex max women 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: 7751589
• MDR Text Key: 116059800
• Report Number: 2184163-2018-00003
• 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
• 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

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FIT FLEX MALE S/M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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