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

Model Number MODERATE

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

Patient Problems Foreign Body Reaction (1868); Gangrene (1873); Unspecified Infection (1930); Urinary Tract Infection (2120)

Event Date 11/01/2014

Event Type  Injury  

Event Description

The consumer stated that in (b)(6) 2014, she purchased and used poise pads for a week.She stated the pads caused blood blisters in the crease between her left leg and genital area, which became infected, causing a severe allergic reaction requiring hospitalization, resulting in gangrene and uti.The consumer stated that she is almost completely healed now and is feeling better.

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.

• 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 719
• Manufacturer Contact: angie masaro ; 2100 winchester rd.; neenah, WI 54956 ; 9207215934
• MDR Report Key: 4731581
• MDR Text Key: 5581655
• Report Number: 2381757-2015-00019
• 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: 03/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MODERATE
• Device Lot Number: AC432201X1746
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• 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: 62 YR