MalfunctionFEN
T-DOC URODYNAMIC CATHETER
Received May 5, 2017 · Event occurred Mar 10, 2017
Report 1720929-2017-00001 · MDR key 6549358
Device
Generic name
Catheter
Product problems
- Leak/Splash
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
STERIS AST RECEIVED (B)(4) REGARDING A T-DOC URODYNAMIC CATHETER. THE PRODUCT SUBJECT OF THE MEDWATCH REPORT IS NOT MANUFACTURED BY STERIS AST. STERIS AST CONTACTED THE USER FACILITY TO DETERMINE THE MANUFACTURER OF THE DEVICE SUBJECT OF THE MEDWATCH. THE MEDWATCH REPORT WILL BE FORWARDED TO THE MANUFACTURER OF THE DEVICE FOR PURPOSES OF INVESTIGATION AND EVALUATION FOR POTENTIAL MEDICAL DEVICE REPORTING UNDER 21 CFR 803.
Description of Event or Problem
REFERENCE (B)(4).