MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-06-20 for TARGIS SYSTEM manufactured by Urologix, Inc..
[3024638]
One day after procedure, patient had bleeding that continued for 1 month. The pt was taking coumadin and had a cystoscopy pre-treatment.
Patient Sequence No: 1, Text Type: D, B5
[10361015]
No disposable devices will be returned because the ae occurred one day after the procedure and the catheter was disposed of.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2012-00003 |
| MDR Report Key | 2822388 |
| Report Source | 06 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-05-10 |
| Date of Event | 2012-04-12 |
| Date Mfgr Received | 2012-05-10 |
| 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 | 7637458134 |
| 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 | 2012-06-20 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-06-20 |