MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for EDAP ABLATHERM INTEGRATED IMAGING manufactured by Edap Tms France Sa.
[71247169]
A (b)(6) man underwent prostate hemiablation with edap ablatherm for gleason 7 prostate cancer in (b)(6) 2016. Patient experienced 3 episodes of urinary retention. Had to be hospitalized on two occasions. First time for clot evaluation from hematuria.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068716 |
| MDR Report Key | 6442255 |
| Date Received | 2017-02-17 |
| Date of Report | 2017-02-06 |
| Date of Event | 2016-12-15 |
| Date Added to Maude | 2017-03-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EDAP ABLATHERM INTEGRATED IMAGING |
| Generic Name | EDAP ABLATHERM INTEGRATED IMAGING |
| Product Code | PLP |
| Date Received | 2017-02-17 |
| Operator | NO INFORMATION |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDAP TMS FRANCE SA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-02-17 |