MAUDE Adverse Event Report: NEENAH COLD SPRING FACILITY DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

Model Number FIT-FLEX INCONTINENCE UNDERWEAR FOR WOMEN, MAXIMUM ABSORBENCY, MEDIUM

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

Patient Problems Irritation (1941); Itching Sensation (1943); Skin Discoloration (2074); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Discomfort (2330)

Event Date 11/01/2017

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 supporting records can be performed.

Event Description

Consumer's caregiver reported that her patient had been diagnosed with reoccurring urinary tract infections while using the depend underwear the past three years.She was hospitalized for one week in (b)(6) 2017 for a kidney problem; she had rash but no uti at the time.She received antibiotics or fluids.Consumer was discharged to a rehab facility but is home now.The caregiver also reported consumer experienced an on-going rash, itching, burning, bleeding to buttocks and between legs which caused discomfort and discoloring to skin; vaginal discharge and odor.She received medical attention for rash and was treated with cream and (b)(6).Rash was improved.

• Brand Name: DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): NEENAH COLD SPRING FACILITY; 1050 cold spring road; neenah WI 54956
• Manufacturer (Section G): NEENAH COLD SPRING FACILITY; 1050 cold spring road; neenah WI 54956
• Manufacturer Contact: chris maertz ; 2100 winchester rd; neenah, WI 54956 ; 9207214907
• MDR Report Key: 8773139
• MDR Text Key: 150470733
• Report Number: 2184163-2019-00004
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FIT-FLEX INCONTINENCE UNDERWEAR FOR WOMEN, MAXIMUM ABSORBENCY, MEDIUM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2019
• 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 Age: 88 YR