MAUDE Adverse Event Report: ADROIT MEDICAL SYSTEMS, INC. HTP1500; PACK, HOT OR COLD, WATER CIRCULATING

Model Number HTP1500

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

Patient Problems Necrosis (1971); Skin Discoloration (2074); Full thickness (Third Degree) Burn (2696)

Event Date 10/10/2020

Event Type  malfunction  

Event Description

Patient states that approximately 2 nights prior to her injury being discovered by the nurse, she had a heating pad over right chest, fell asleep and awoke with her right chest burning.Patient has a round, full thickness burn wound (2nd degree), burn measuring 2cm x 2.5cm x 0.1cm, 100% yellow necrotic slough with peri-wound discoloration.Burn entire area measuring 4cm x 8cm.

• Brand Name: HTP1500
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): ADROIT MEDICAL SYSTEMS, INC.; 1146 carding machine rd.; loudon TN 37774
• MDR Report Key: 10785092
• MDR Text Key: 214596939
• Report Number: 10785092
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/28/2020,10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HTP1500
• Device Catalogue Number: HTP1500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2020
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17885 DA
• Patient Weight: 102