PROVOX BRUSH
Received Oct 10, 2007 · Event occurred Jun 30, 2006
Report 8032044-2007-00016 · MDR key 924691
Device
Generic name
Cleaning Brush For Voice Prosthesis
Manufacturer
Atos Medical AbModel number
PROVOX BRUSHCatalog number
7204
Lot number
0502005 (UNCERTAIN)
Product problems
- Foreign material
Patient
YR
- Foreign body, removal of
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
DURING A PT MEETING IN ANOTHER COUNTRY, A PT INFORMED OUR REP THAT HE SOME TIME AGO HAD SOME LUNG PROBLEMS AND WENT TO SEE A DOCTOR. X-RAY REVEALED A PROVOX BRUSH IN THE LUNG WHICH CONSEQUENTLY WAS REMOVED. THE PT DID NOT FEEL ANY DISCOMFORT AFTERWARDS. OUR REP FORWARDED THE INFO TO US AS A COMPLAINT.
Additional Manufacturer Narrative
INSTRUCTIONS FOR USE HAVE BEEN EXAMINED AND CORRECT HANDLING IS CLEARLY DESCRIBED. IN ORDER TO DROP THE BRUSH INTO THE TRACHEA, IT MUST BE USED COMPLETELY IN VIOLATION WITH THE INSTRUCTIONS FOR USE. THE HOSPITAL HAS DONE THE SAME ASSESSMENT OF THE EVENT AND THEY HAVE NOT REPORTED IT TO THE AUTHORITIES. THE PT HAS BEEN INFORMED ON CORRECT USE OF THE BRUSH. CASE HAS BEEN CLOSED. THIS EVENT WAS NOT INITIALLY REPORTED AS AN MDR. DUE TO INCIDENT REPORT 6/29/2007, (MFR #8032044-2007-00009) REVIEW OF FORMER SIMILAR EVENTS WAS DONE AND WE DECIDED TO REPORT THIS ISSUE.
Remedial action
- Other