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

Health Effect - Clinical Codes	Burn(s) (1757); Blister (4537)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): HEBEI HOUDE HANFANG MEDICAL DEVICES GROUP CO.,LTD
• MDR Report Key: 18960020
• Report Number: MW5153050
• Device Sequence Number: 11172830
• Product Code: KGX
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date (Section B): 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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male