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

Model Number LARGE

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Date 11/14/2015

Event Type  Injury  

Manufacturer Narrative

A document and records review was performed on the reported lot.Documentation assessed includes: manufacturing, quality audit, production, raw material and device history records.This assessment found no anomalies that may have attributed to the reported issue; therefore the complaint could not be confirmed.Complaint sample was not returned therefore a product evaluation could not be performed.The cause of the reported complaint could not be determined.Information from this incident will be included in our product complaint and mdr trend analysis.

Event Description

Consumers wife called and stated her husband was taken to the hospital on (b)(6), the doctor diagnosed him with a uti, was given iv antibiotics.He is better now and home from the hospital.Consumer has been using the product for almost a year now.

• 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 Contact: jean nielsen ; 2100 winchester rd.; neenah, WI 54956 ; 9207216517
• MDR Report Key: 5293327
• MDR Text Key: 33401324
• Report Number: 2184163-2015-00001
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: LARGE
• Device Lot Number: LF516316X1841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2015
• 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: 75 YR