FDA Adverse Event
Injury
Summary report: N
PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT
MDR report key: 870509
·
Received June 26, 2007
Report
- Report Number
- 3002591507-2007-00003
- Event Type
- Injury
- Date Received
- June 26, 2007
- Date of Event
- February 16, 2007
- Report Date
- June 19, 2007
- Manufacturer
- PROSTALUND OPERATIONS AB
- Product Code
- MEQ
- PMA / PMN Number
- P010055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Description of Event or Problem · 1
IN 2007: (1 WEEK POST PROCEDURE) PT COMPLAINED OF IRRITATIVE SYMPTOMS, AND PARTIAL INCONTINENCE. ONE MONTH LATER, (5 WKS POST PROCEDURE) PT CONTINUES TO HAVE PROBLEMS WITH INCONTINENCE; COMES TO CLINIC WEARING DIAPER. THE FOLLOWING MONTH, (8 WKS POST PROCEDURE) UPON CYSTOSCOPY, DR'S OBSERVE "PARTIAL NECROSIS OF EXTERNAL SPHINCTER AND TRIGONE ALONG WITH SOME OBSTRUCTIVE NECROTIC DEBRIS". DR. THATS DURING THE CYSTOSCOPY, HE "ROUGHLY" MEASURED THE BASE TO APEX LENGTH AGAINST THE TURP LOOP DEVICE WHICH IS KNOWN TO BE 3.0 CM. AT THAT TIME, HE FOUND THE BASE TO APEX RANGE TO FALL BELOW THE 3.0 CM LENGTH OF THE TURP LOOP. TWO MONTHS LATER, DR. STATES THAT THE PT IS PARTIALLY INCONTINENT AT PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT | 78MEQ | MEQ | PROSTALUND OPERATIONS AB | PL CORETHERM SE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Disability | PROZAC| AVODART| DITROPAN| FLOMAX| WELLBUTRIN| NEXIUM| ADDERALL| AMBIEN| CLONIPIN| TRAZODONE |