CD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-08 for CD manufactured by Urologix, Inc..

Event Text Entries

[21754846] (b)(6). Dear sirs: my urologist gave me a copy of your disc titled fiembrace life without enlarged prostate cooled thermo therapy. I reviewed the disc and based on the information contained on the disc i had my urologist perform the procedure. The information on the disc is misleading and in some cases completely false! When i had the procedure i was told that i would have to have a catheter for two weeks and not as the disc indicated that i would be leaving without one or at the most two or three days and remove it at home. I had extreme rectal pain at home as a result of the probe used during the procedure. I had bladder spams at home after the procedure and it was never mentioned on the disc. I had the procedure based on the information you provided on the disc. That information was either wrong or completely misleading. Because of the misleading information you placed on the disc i am sending a copy of this letter to the fda as well as reporting it to you. I will never recommend your procedure to anyone because of the false information contained on your disc.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5028068
• MDR Report Key: 2875378
• Date Received: 2012-12-08
• Date of Report: 2012-12-08
• Date of Event: 2012-11-17
• Date Added to Maude: 2012-12-18
• 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: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CD
• Generic Name: EMBRACE LIFE PROSTATE WITHOUT ENLARGED
• Product Code: MEQ
• Date Received: 2012-12-08
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UROLOGIX, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2012-12-08