MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-07-10 for TARGIS SYSTEM 500A manufactured by Urologix, Inc..
[2872392]
Pt experienced irritative symptoms post treatment; burning, frequency and starting and stopping during urination. The doctor performed a cytoscopy on the pt and saw what looked like a defect in the urethra in the area of the verumontanum up to near the bladder neck, but not all the way up to the bladder neck. The pt was put on antibiotics but as of now the pt has not had relief.
Patient Sequence No: 1, Text Type: D, B5
[10022057]
Despite several attempts, additional information has not been obtained to date. Additional attempts to follow-up with the clinician/staff will be made and if possible, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2012-00002 |
| MDR Report Key | 2650142 |
| Report Source | 05,06 |
| Date Received | 2012-07-10 |
| Date of Report | 2012-07-05 |
| Date of Event | 2012-02-09 |
| Date Mfgr Received | 2012-06-05 |
| Date Added to Maude | 2012-07-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. GEORGIANN KEYPORT |
| Manufacturer Street | 14405 21ST AVE N |
| Manufacturer City | MINNEAPOLIS MN 554472000 |
| Manufacturer Country | US |
| Manufacturer Postal | 554472000 |
| Manufacturer Phone | 7637458134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TARGIS SYSTEM |
| Generic Name | MICROWAVE DELIVERY SYSTEM, PDT CODE MEQ |
| Product Code | MEQ |
| Date Received | 2012-07-10 |
| Model Number | 500A |
| Lot Number | 111215MCA2 |
| ID Number | 040407-01 |
| Device Expiration Date | 2013-11-01 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UROLOGIX, INC. |
| Manufacturer Address | 14405 21ST AVE NORTH MINNEAPOLIS MN 55447200 US 55447 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-10 |