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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UROLOGIX, LLC COOLWAVE CTT

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UROLOGIX, LLC COOLWAVE CTT Back to Search Results
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.
 
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Brand NameCOOLWAVE
Type of DeviceCTT
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 Key8197830
MDR Text Key131443674
Report Number2133936-2018-00001
Device Sequence Number1
Product Code MEQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPT1036
Device Catalogue Number410097-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
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 Unkown

Patient Treatment Data
Date Received: 12/26/2018 Patient Sequence Number: 1
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