THD REVOLUTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-11 for THD REVOLUTION manufactured by Thd Spa.

Event Text Entries

[40326344] Pt admitted for transanal hemorrhoidal dearterialization procedure using thd revolution device. It was noted near the end of the procedure that the pt had some blistered areas around her anus. It was determined that these were burns from the light source attached to the thd revolution hand piece used for the case. The representative for the thd revolution was in the operating room at the time of the procedure and confirmed that all pieces were attached correctly prior to use of the device. After notifying the mfr of the event, the representative from the mfr advised our facility administrator that even a small gap between the light source and the hand piece could generate heat causing a burn to occur. Diagnosis or reason for use: prolapsing internal hemorrhoids.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5060888
• MDR Report Key: 5500078
• Date Received: 2016-03-11
• Date of Report: 2016-03-03
• Date of Event: 2015-02-26
• Date Added to Maude: 2016-03-15
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THD REVOLUTION
• Generic Name: HEMORRHOIDAL DOPPLER
• Product Code: FER
• Date Received: 2016-03-11
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THD SPA
• Manufacturer Address: IT

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-03-11