MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-26 for COOLWAVE PT1036 410097-001 manufactured by Urologix, Llc.
[131443674]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2133936-2018-00001 |
| MDR Report Key | 8197830 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-14 |
| Date Added to Maude | 2018-12-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. MARK SWANSON |
| Manufacturer Street | 14406 21ST AVENUE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7634757648 |
| Manufacturer G1 | UROLOGIX, LLC |
| Manufacturer Street | 14406 21ST AVENUE N |
| Manufacturer City | MINNEAPOLIS, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOLWAVE |
| Generic Name | CTT |
| Product Code | MEQ |
| Date Received | 2018-12-26 |
| Model Number | PT1036 |
| Catalog Number | 410097-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UROLOGIX, LLC |
| Manufacturer Address | 14406 21ST AVENUE N MINNEAPOLIS, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-12-26 |