MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION - CONWAY MILL POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

Model Number POISE LINERS LONG

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Date 03/21/2016

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

This is a non-us event.The consumer stated that she was diagnosed with kidney infection, and that her doctor stated the infection could have been from the pads she was using.She was prescribed medication and began taking it on (b)(6).The consumer reported on (b)(6) that she was symptom-free and her infection appeared to be resolved.

• Brand Name: POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION - CONWAY MILL; 480 exchange ave.; conway AR 72032 7191
• Manufacturer Contact: angie masaro ; 2100 winchester rd.; neenah, WI 54956 ; 9207215934
• MDR Report Key: 5567357
• MDR Text Key: 42383439
• Report Number: 2381757-2016-00013
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: POISE LINERS LONG
• Device Lot Number: AC527103X0537
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 52 YR