MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION PARIS PLANT GOODNITES; GARMENT, PROTECTIVE, FOR INCONTINENCE

Model Number GIRL, S-M

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

Patient Problems Abscess (1690); Fever (1858); Rash (2033); Discomfort (2330)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) and quality records were reviewed.These documents demonstrate that procedures were correctly followed.Complaints which are serious in nature are reviewed on a regular basis or for due cause to provide visibility and escalation.In addition, complaints are also monitored for trending on a monthly cadence.No further information is available at this time.

Event Description

This is a non-us event.This occurred in (b)(6).The consumer stated that her daughter developed a rash with two abscesses that needed to be drained and resulted in hospitalization.One abscess was drained, the second became infected and had to be surgically removed.Consumer reported that her child is improving and that the abscess is closing up.Two different packages of the product were used.The other package is reported under 1650783-2018-00002.

• Brand Name: GOODNITES
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION PARIS PLANT; 2466 farm road 137; paris TX 75460
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION PARIS PLANT; 2466 farm road 137; paris TX 75460
• Manufacturer Contact: marian vargas ; 2100 winchester road; neenah, WI 54956 ; 9207215889
• MDR Report Key: 8015199
• MDR Text Key: 125329523
• Report Number: 1650783-2018-00001
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GIRL, S-M
• Device Lot Number: PA800715X1611
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2018
• 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: 30 MO