MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-06-30 for TARGIS SYSTEM 410097-001 manufactured by Urologix, Inc..
[20659018]
It was reported that a small leak was discovered at the bottom of the coude tip. The treatment was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[20959797]
The evaluation showed that the location balloon had a small leak due to either an incomplete fill, void, or air bubbles in the adhesive.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2014-00003 |
| MDR Report Key | 3901948 |
| Report Source | 00 |
| Date Received | 2014-06-30 |
| Date of Report | 2014-06-27 |
| Date of Event | 2014-05-30 |
| Date Mfgr Received | 2014-05-30 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-07-21 |
| 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 | MARGARET BATCHELDER |
| Manufacturer Street | 14404 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 FOR BPH. |
| Product Code | MEQ |
| Date Received | 2014-06-30 |
| Returned To Mfg | 2014-06-09 |
| Model Number | 410097-001 |
| Catalog Number | 410097-001 |
| Lot Number | 130926MCA1 |
| Device Expiration Date | 2015-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-06-30 |