MAUDE Adverse Event Report: C2DX, INC T PUMP PAD; PACK, HOT OR COLD, WATER CIRCULATING

Model Number TP700

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

Patient Problem Burn(s) (1757)

Event Date 03/01/2023

Event Type  Injury  

Event Description

Upon examination of patient's skin partial thickness injury to bilateral thighs and right lateral buttock was found.The wounds were consistent with the pattern of the k pad (t pump pad) heating pad that the patient had reported using.

Manufacturer Narrative

Per the device ifu: rechecking the patient's skin condition: recheck the entire area of the patient's skin condition that is in contact with the pad at least every 30 minutes: note any change in the skin integrity that relates to excessive moisture - dry the skin surface by wiping away the moisture; color of the epidermis; skin texture·patient's skin condition is acceptable to continue therapy.

• Brand Name: T PUMP PAD
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): C2DX, INC; 555 e eliza st suite a; schoolcraft MI 49087
• MDR Report Key: 16732346
• MDR Text Key: 313214875
• Report Number: 3015489752-2023-00001
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• PMA/PMN Number: K073675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TP700
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose