MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION GOODNITES UNDERPANTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

Model Number NIGHTTIME UNDERWEAR FOR BOYS, S-M

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

Patient Problems Fever (1858); Pain (1994); Skin Irritation (2076); Caustic/Chemical Burns (2549); Partial thickness (Second Degree) Burn (2694)

Event Date 06/29/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturing facility is conducting a review of the dhr (device history record) and supporting quality records.

Event Description

A mother reported that her son experienced a second degree chemical burn from wearing the goodnites night time underwear.Everywhere the product touched his skin turned red and after overnight use, his skin became more red and blistered and bled.She took him to the walk-in-clinic.The provider at the clinic recommended she use desitin and diagnosed him with a chemical burn.They went home and desitin was applied.They also stopped using the product.Two hours after arriving home, the blisters worsened and the skin on his bottom was completely gone, he had pain and a fever.She then took him to children's hospital.From children's hospital he was transported via ambulance to a burn unit where he was diagnosed with second degree chemical burns and was admitted for three days.While admitted to the burn unit, he was put under iv anesthesia for a surgical scrub down in the operating room.Treatments were also done with silvadene sheets to care for the burns.He received pain medication and was prescribed a cream that was applied to the burns.Her son was released from the hospital and was home and feeling better.He had a follow up appointment with the burn unit and it was confirmed he is doing better.He was no longer blistered and burns were healing.They will follow up again with the burn unit.

• Brand Name: GOODNITES UNDERPANTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION; 2100 winchester rd.; neenah WI 54956
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION; 2100 winchester rd.; neenah WI 54956
• Manufacturer Contact: chris maertz ; 2100 winchester rd; neenah, WI 54956 ; 9207214907
• MDR Report Key: 8840986
• MDR Text Key: 152629455
• Report Number: 3003701733-2019-00384
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NIGHTTIME UNDERWEAR FOR BOYS, S-M
• Device Lot Number: PA907215B2142
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2019
• 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; Required Intervention
• Patient Age: 3 YR