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

Model Number HTP1500

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Itching Sensation (1943); Rash (2033); Partial thickness (Second Degree) Burn (2694)

Event Date 07/29/2021

Event Type  Injury  

Event Description

The elderly patient was admitted to the medical inpatient unit.The patient herself discovered a wound on her back (left scapula area) that started to itch.When scratching the area, she felt multiple raised bumps and looked in the mirror to view the area.She called nurse to the room and lifted the back of her shirt up to reveal a patterned burn mark consistent with the textured pad of a seabrook heating pad.

• 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: 12335873
• MDR Text Key: 267061213
• Report Number: 12335873
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2021
• 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: 22630 DA
• Patient Weight: 67