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

Model Number MODERATE

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

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Fungal Infection (2419)

Event Date 01/01/1999

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 reported she has been experiencing yeast infections for the last 20 years while using the product.The yeast infection traveled to the inside of her stomach and she was hospitalized.She recently sought medical attention for a red itchy rash in vaginal area.Medication was prescribed for yeast infection.Upon completing the medication her symptoms improved but did not resolve.She is currently taking prednisone.

Manufacturer Narrative

This is a follow up to report new information was received from the consumer.Consumer reported she had not been hospitalized due to her yeast infections.Report type: follow-up 1.

Event Description

This is a follow-up to report new information was received from the consumer.Consumer reported she had not been hospitalized due to her yeast infections.

• Brand Name: POISE PADS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION; 2100 winchester rd.; neenah WI 54956
• MDR Report Key: 8851146
• MDR Text Key: 152955203
• Report Number: 3003701733-2019-00400
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MODERATE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 71 YR