MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-24 for TARGIS SYSTEM N/A manufactured by Urologix, Inc..
[3689545]
Urologix field service was contacted by a nurse at a urologist's clinic regarding a patient injury. The nurse explained that a patient had been seen by internal medicine (b)(6) 2013 and they (urologist's clinic) were notified that the patient had a rectal fistula or burn that was most likely caused by the tumt procedure on (b)(6) 2013. The patient was admitted and was being treated for the injury. The nurse said from the patient printout that the procedure was completed successfully without any issues.
Patient Sequence No: 1, Text Type: D, B5
[10960371]
The treatment file retrieved from the control unit was reviewed. It was determined that the control unit operated as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2013-00004 |
| MDR Report Key | 3244943 |
| Report Source | 05,06 |
| Date Received | 2013-07-24 |
| Date of Report | 2013-07-22 |
| Date of Event | 2013-06-25 |
| Date Mfgr Received | 2013-06-26 |
| Device Manufacturer Date | 2012-01-04 |
| Date Added to Maude | 2013-07-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. HOPE PRZYBILLA |
| Manufacturer Street | 14405 21ST AVENUE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7634751400 |
| Manufacturer G1 | UROLOGIX, INC. |
| Manufacturer Street | 14405 21ST AVENUE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TARGIS SYSTEM |
| Generic Name | MICROWAVE DELIVERY SYSTEM |
| Product Code | MEQ |
| Date Received | 2013-07-24 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | 120104MHA1 |
| ID Number | N/A |
| Device Expiration Date | 2013-12-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UROLOGIX, INC. |
| Manufacturer Address | 14405 21ST AVENUE NORTH MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-24 |