MAUDE Adverse Event Report: UROLOGIX, LLC COOLWAVE; CTT

Model Number PT1036

Device Problem Protective Measures Problem (3015)

Patient Problem Fistula (1862)

Event Type  Injury  

Event Description

On 23aug2018 we were contacted by clinician from (b)(6) medical ((b)(6) area, (b)(6)) about a coolwave machine in need of preventative maintenance.The request stemmed from a report of a ctt patient developing a rectal fistula post procedure.Procedure date is currently unk.First report of the fistula is currently unk.

• Brand Name: COOLWAVE
• Type of Device: CTT
• Manufacturer (Section D): UROLOGIX, LLC; 14406 21st avenue n; minneapolis,
• Manufacturer (Section G): UROLOGIX, LLC; 14406 21st avenue n; minneapolis,
• Manufacturer Contact: mark swanson ; 14406 21st avenue n; minneapolis, MN 55447 ; 7634757648
• MDR Report Key: 8197830
• MDR Text Key: 131443674
• Report Number: 2133936-2018-00001
• Device Sequence Number: 1
• Product Code: MEQ
• UDI-Device Identifier: M876PT10360
• UDI-Public: M876PT10360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PT1036
• Device Catalogue Number: 410097-001
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability