MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-05-16 for TARGIS SYSTEM TC1121C manufactured by Urologix, Inc..
[3500910]
On (b)(6) 2013, urologix, inc. Regional sales director (rsd) reported receiving information during a conversation with a physician that a patient had presented with a burn on his scrotum and the base of his penis following his microwave treatment. No additional information was provided to the rsd at that time. Since the event was initially reported, urologix has attempted contact with the physician to obtain additional investigational information more than 12 times with no success. Urologix will continue to contact the physician office and will submit supplements to the initial mdr as information can be obtained.
Patient Sequence No: 1, Text Type: D, B5
[3580567]
On (b)(6) 2013, urologix, inc. Regional sales director (rsd) reported receiving information during a conversation with a physician that a patient had presented with a burn on his scrotum and the base of his penis following his microwave treatment. No additional information was provided to the rsd at that time. Since the event was initially reported, urologix has attempted contact with the physician to obtain additional investigational information more than 12 times with no success. Urologix will continue to contact the physician office and will submit supplements to the initial mdr as information can be obtained.
Patient Sequence No: 1, Text Type: D, B5
[10761491]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[11024545]
Urologix originally reported: on (b)(6) 2013, urologix inc. Regional sales director (rsd) reported receiving information during a conversation with a physician that a patient had presented with a burn on his scrotum and the base of his penis following his microwave treatment. No additional information was provided to the rsd at that time. Prior to filing the mdr, urologix unsuccessfully attempted to contact the physician on numerous occasions to obtain additional investigational information. After filing the mdr, urologix continued attempting to contact the physician. Urologix was successful in contacting the president of the practice. The president said he was hopeful that the patient would be ok and that he is under the care of a specialist. The president provided no further information. A chronology of physician contact attempts is provided. The treatment device was never returned to urologix for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2013-00002 |
| MDR Report Key | 3116886 |
| Report Source | 05,07 |
| Date Received | 2013-05-16 |
| Date of Report | 2013-04-17 |
| Date of Event | 2013-03-05 |
| Date Mfgr Received | 2013-04-17 |
| Date Added to Maude | 2013-05-17 |
| 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 | MRS. HOPE PRZYBILLA |
| Manufacturer Street | 14405 21ST AVENUE NORTH |
| 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 | 2013-05-16 |
| Model Number | TC1121C |
| Catalog Number | TC1121C |
| Lot Number | ACP10101811B |
| ID Number | N/A |
| Device Expiration Date | 2013-08-01 |
| Operator | OTHER |
| 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. AVENUE NORTH MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-16 |