MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-07-06 for TARGIS SYSTEM manufactured by Urologix, Inc.
[19043694]
Manufacturer cannot contact the patient as no information is available and the product was not returned. The problem cannot be investigated or substantiated at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19106090]
A patient reported a voluntary mrd to fda that 2001, a urologist performed a microwave heat treatment on him. The treatment was reported to take about 30 min. (b)(6) weeks later, the patient complained that he could not get an erection or ejaculate. The patient reported having the same problem ten years later. This was reported to fda on (b)(4) 2012, under mdr report key (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2133936-2012-00006 |
| MDR Report Key | 2642882 |
| Report Source | 04 |
| Date Received | 2012-07-06 |
| Date of Report | 2012-07-06 |
| Date of Event | 2001-01-15 |
| Date Mfgr Received | 2012-04-19 |
| Date Added to Maude | 2012-07-06 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS GEORGIANN KEYPORT |
| Manufacturer Street | 14405 21ST AVENUE N |
| Manufacturer City | MINNEAPOLIS MN 554472000 |
| Manufacturer Country | US |
| Manufacturer Postal | 554472000 |
| Manufacturer Phone | 7637458134 |
| Single Use | 0 |
| 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 | 2012-07-06 |
| 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 N MINNEAPOLIS MN 55447200 US 55447 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-06 |