FDA Adverse Event
Injury
Summary report: N
PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT
MDR report key: 841833
·
Received April 23, 2007
Report
- Report Number
- 3002591507-2007-00002
- Event Type
- Injury
- Date Received
- April 23, 2007
- Report Date
- April 16, 2007
- Manufacturer
- PROSTALUND OPERATIONS AB
- Product Code
- MEQ
- PMA / PMN Number
- P010055
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
INITIAL REPORT. ONE PATIENT TREATED WITH PROSTALUND'S CORETHERM EQUIPMENT FOR TREATMENT OF BENIGN PROSTATIC HYPERPLASIA HAS HAD HIS SFINCTER DAMAGED AND THE PT IS TOTALLY INCONTINENT. PROSTALUND HAS CONTACTED THE HOSP FOR A MEETING (WITHIN 14 DAYS) TO REVIEW PRINTOUT REPORTS, PT DATA AND TO REVIEW THE DATA TOGETHER WITH THE DR WHO PERFORMED THE TREATMENT. FOLLOW-UP REPORT INCLUDING TECHNICAL AND MEDICAL ANALYSIS BY OUR MEDICAL EXPERT IS PLANNED TO BE AVAILABLE BEFORE END OF MAY (MAY 31). REPORTS REGARDING THIS EVENT HAVE ALSO BEEN SENT TO THE APPROPRIATE AUTHORITY IN ANOTHER COUNTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT | 78 MEQ | MEQ | PROSTALUND OPERATIONS AB | PL CORETHERM | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |