FDA Adverse Event Injury Summary report: N

PROSTATRON

MDR report key: 312827 · Received January 16, 2001

Report

Report Number
2133936-2001-00001
Event Type
Injury
Date Received
January 16, 2001
Date of Event
March 26, 1999
Report Date
January 16, 2001
Manufacturer
UROLOGIX, INC.
Product Code
MEQ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

UROLOGIX REC'D A MEDWATCH REPORT FORM FROM THE FDA ON 01/10/2001 (MW1020463). UROLOGIX DID NOT RECEIVE ENOUGH INFORMATION FROM THE MEDWATCH REPORT (MW1020463) TO INVESTIGATE THIS EVENT FURTHER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1683 PROSTATRON HYPERTHERMIA, RF/MICROWAVE SYSTEM MEQ UROLOGIX, INC. UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN