MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-06-25 for TARGIS SYSTEM 410099-001 manufactured by Urologix, Inc..
[19192791]
The patient experienced extreme pain at 15 minutes then the procedure was ended.
Patient Sequence No: 1, Text Type: D, B5
[19409327]
The doctor remarked that the pt prostate was very large and so he used the largest ctc advance catheter available. The disposable device was not returned. A disk with the treatment file from the control unit was sent back, but disk was blank. All mfg and quality assurance testing was carried out in accordance with the standard procedures and the disposable unit met its specs at the time of release.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2012-00005 |
| MDR Report Key | 2822419 |
| Report Source | 05 |
| Date Received | 2012-06-25 |
| Date of Report | 2012-06-21 |
| Date of Event | 2012-05-21 |
| Date Mfgr Received | 2012-05-24 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2012-11-08 |
| 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 GEORGIANN KEYPORT |
| Manufacturer Street | 14405 TWENTY-FIRST AVE. NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7637451562 |
| Manufacturer G1 | UROLOGIX, INC. |
| Manufacturer Street | 14405 TWENTY-FIRST AVE. NORTH |
| 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 | 2012-06-25 |
| Catalog Number | 410099-001 |
| Lot Number | 120405MLA1 |
| Device Expiration Date | 2014-03-01 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UROLOGIX, INC. |
| Manufacturer Address | 14405 TWENTY-FIRST AVE. NORTH MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-25 |