FDA Adverse Event
Other
Summary report: N
PROVOX BRUSH
MDR report key: 926115
·
Received October 12, 2007
Report
- Report Number
- 8032044-2007-00017
- Event Type
- Other
- Date Received
- October 12, 2007
- Date of Event
- August 26, 2006
- Manufacturer
- ATOS MEDICAL AB
- Product Code
- EWL
- PMA / PMN Number
- EXEMPTED
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION HAS REVEALED THAT THE PT HAS USED THE BRUSH FOR FIVE (5) YEARS. RECOMMENDATION IS 1 MONTH. THE PT RECEIVED ADDITIONAL INFORMATION. WE ALSO CONTINUOUSLY EDUCATE PTS, PROFESSIONALS AND SALES PERSONS OF THE CORRECT USE OF THE DEVICES. ALL MANUALS ARE ALSO DOWNLOADABLE FROM OUR WEBSITE. NO FURTHER ACTIONS. CASE HAS BEEN CLOSED. THIS EVENT WAS NOT INITIALLY REPORTED AS AN MDR. DUE TO INCIDENT REPORT IN 2007, (MFR#8032044-2007-00009) REVIEW ACCORDING TO OUR POSTMARKET SURVEILLANCE PROCEDURE OF FORMER SIMILAR EVENTS WAS DONE AND WE DECIDED TO REPORT THIS ISSUE.
Description of Event or Problem · 1
THE BRISTLE PART OF THE BRUSH BROKE OFF DURING CLEANING AND FELL DOWN IN THE PTS LUNG. THE PARTS WERE RETRIEVED DURING RADIOSCOPIC EXAMINATION. NO POSTOPERATIVE COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROVOX BRUSH | CLEANING BRUSH FOR VOICE PROSTHESIS | EWL | ATOS MEDICAL AB | PROVOX BRUSH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |