MAUDE Adverse Event Report: HEBEI HOUDE HANFANG MEDICAL DEVICES GROUP CO.,LTD XITOX; TAPE AND BANDAGE, ADHESIVE

Patient Problems Burn(s) (1757); Blister (4537)

Event Date 12/22/2023

Event Type  Injury  

Event Description

Customer experienced blisters and burns to his feet.Type ii diabetic for approximately 30 years.Indication for use: deep cleansing foot pads.

• Brand Name: XITOX
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): HEBEI HOUDE HANFANG MEDICAL DEVICES GROUP CO.,LTD
• MDR Report Key: 18960020
• MDR Text Key: 338499127
• Report Number: MW5153050
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male