MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRANSWARMER INFANT TRANSPORT MATTRESS WITH WARMGEL; PACK, HOT OR COLD, DISPOSABLE

Patient Problems Superficial (First Degree) Burn (2685); Skin Inflammation/ Irritation (4545)

Event Date 10/08/2023

Event Type  malfunction  

Event Description

On day 2 of life, neonate began to develop reddened abnormal skin assessment.The patient¿s skin then developed white areas of plaque, concerning for fungal infection.Due to the patient¿s clinical acuity and abnormal skin assessment, the patient was transferred to a tertiary facility for higher level of care management.Upon arrival to the outside facility, there was possibility for questionable burn to the skin.The neonate had been on the warming mattress prior to and during transfer.

• Brand Name: TRANSWARMER INFANT TRANSPORT MATTRESS WITH WARMGEL
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate dr; trumbull CT 06611
• MDR Report Key: 18010760
• MDR Text Key: 326607066
• Report Number: 18010760
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Sex: Male