TITAN OTR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-11 for TITAN OTR manufactured by Coloplast Corp..

Event Text Entries

[45367214] In late (b)(6) 2011. I was fitted with a s/p inflatable prosthesis at the (b)(6) by dr. (b)(6), on follow up visit, i complained of the pain in my groin and testicle area. He had no solution for me. I am attaching this office visit with this form, because it can better explain what i am trying to say. In (b)(6) 2011, i did a follow up visit with dr. (b)(6) and complained about the pain in my testicles or scrotum area. He had no answer for me. I have been in pain since the surgery. On 2011 till present day 2016, i believe that dr. (b)(6) used me as a test patient for this device without my knowing it. He didn't show me the device until he thought that it wasn't time for me to use it when he tried to pump it up: i was too tender and it never worked. I will send a picture/photo of the medical device.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5062227
• MDR Report Key: 5652254
• Date Received: 2016-05-11
• Date of Report: 2016-04-19
• Date of Event: 2011-11-01
• Date Added to Maude: 2016-05-13
• 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
• 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: 0

Device Details

• Brand Name: TITAN OTR
• Generic Name: ERECTILE DYSFUNCTION S/P INFLATABLE PROSTHESIS
• Product Code: LST
• Date Received: 2016-05-11
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COLOPLAST CORP.
• Manufacturer Address: MINNEAPOLIS MN US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-05-11